Abatacept

Name: Abatacept

What happens if I miss a dose?

Call your doctor for instructions if you miss your abatacept dose.

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant fusion protein.1 2 3 4 5

Cautions for Abatacept

Contraindications

None known.1

Warnings/Precautions

Warnings

Infectious Complications

Serious infections (including pneumonia, cellulitis, urinary tract infections, bronchitis, diverticulitis, and acute pyelonephritis) reported, particularly in patients receiving concomitant TNF-blocking agents.1

Concomitant use of abatacept and TNF-blocking agents is not recommended.1 Monitor patients being switched from TNF-blocking agents to abatacept for infection.1 (See Specific Drugs and Laboratory Tests under Interactions.)

Discontinue abatacept if serious infection develops.1 Closely monitor patients who develop new infections.1

Use caution in patients with a history of recurring infections, underlying conditions that may predispose them to infections, or chronic, latent, or localized infections.1

Evaluate all patients for active or latent tuberculosis prior to initiation of abatacept therapy.1 When indicated, initiate appropriate antimycobacterial regimen for the treatment of latent tuberculosis infection prior to abatacept.1

Hepatitis B Virus (HBV) Reactivation

Use of antirheumatic drugs associated with reactivation of HBV infection in patients who are chronic carriers of the virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).1 Screen patients at risk prior to initiation of therapy.1

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis or anaphylactoid reactions reported.1 6 Other allergic reactions (e.g., hypotension, urticaria, dyspnea) reported rarely.1

If serious hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).1

Acute Infusion Reactions

Acute infusion reactions (e.g., dizziness, headache, hypertension, hypotension, dyspnea, nausea, flushing, urticaria, cough, pruritus, rash, wheezing) reported within 1 hour after IV infusion.1

General Precautions

Vaccination

Vaccine efficacy may be reduced; avoid live virus vaccines during abatacept therapy or within 3 months after discontinuance of the drug.1 (See Vaccines under Interactions and see Pediatric Use under Cautions.)

COPD

Possible exacerbations of COPD, cough, rhonchi, and dyspnea.1

Use with caution; careful monitoring recommended for worsening of respiratory function.1

Immunosuppression

Possibility exists for agents that inhibit T-cell activation, including abatacept, to affect host defenses against infection and malignancies.1 (See Infectious Complications and also see Malignancies and Lymphoproliferative Disorders, under Cautions.)

Malignancies and Lymphoproliferative Disorders

Lymphoma and lung cancer reported more frequently in patients receiving abatacept versus control.1 Rheumatoid arthritis patients, especially with highly active disease, may be at increased risk of lymphoma.1 6

Other malignancies (e.g., myelodysplastic syndrome, melanoma, breast, bile duct, bladder, cervical, endometrial, ovarian, prostate, renal, thyroid, uterine, and nonmelanoma skin cancer) also reported.1

Role of abatacept in the development and course of malignancies not fully determined.1 6

Immunogenicity

Antibodies to abatacept may develop; not associated with decreased clinical response or increased adverse events.1

Blood Glucose Testing

Parenteral preparations containing maltose, including abatacept injection, may cause falsely elevated results in blood glucose determinations that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).1 (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy for the management of juvenile idiopathic arthritis established in pediatric patients ≥6 years of age.1 Safety and efficacy not established in children <6 years of age; use in this age group not recommended.1

Safety and efficacy for uses other than juvenile idiopathic arthritis not established in pediatric patients.1

Review vaccination status of the child and administer all age-appropriate vaccines prior to initiation of abatacept.1

Adverse effects reported in children similar to those reported in adults.1

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.1

Possible increased incidence of infections and malignancies in geriatric patients; use with caution.1 (See Infectious Complications and also Malignancies and Lymphoproliferative Disorders under Cautions.)

Common Adverse Effects

Upper respiratory infection, nasopharyngitis, headache, nausea.1

Pronunciation

(ab a TA sept)

Contraindications

There are no contraindications listed within the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to abatacept or any component of the formulation; patients with, or at risk of sepsis syndrome (eg, immunocompromised, HIV positive)

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Storage

Prefilled syringe: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light.

Powder for injection: Prior to reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. After dilution in NS, may be stored for up to 24 hours at room temperature or refrigerated at 2°C to 8°C (36°F to 46°F). Must be used within 24 hours of reconstitution.

Drug Interactions

Anakinra: May enhance the adverse/toxic effect of Abatacept. Avoid combination

Anti-TNF Agents: May enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Avoid combination

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: Abatacept may enhance the adverse/toxic effect of Belimumab. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

RiTUXimab: May enhance the adverse/toxic effect of Abatacept. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tocilizumab: May enhance the adverse/toxic effect of Abatacept. Avoid combination

Tofacitinib: Abatacept may enhance the adverse/toxic effect of Tofacitinib. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions have been reported with intravenous administration; may occur with first infusion. Some reactions (hypotension, urticaria, dyspnea) occurred within 24 hours of infusion. Discontinue treatment if anaphylaxis or other serious allergic reaction occurs; medication for the treatment of hypersensitivity reactions should be available for immediate use.

• Infections: Serious and potentially fatal infections (including tuberculosis and sepsis) have been reported, particularly in patients receiving concomitant immunosuppressive therapy. RA patients receiving a concomitant TNF antagonist experienced an even higher rate of serious infection; monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept. Caution should be exercised when considering the use in any patient with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued.

• Malignancy: Use may affect defenses against malignancies (via T cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.

Disease-related concerns:

• COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution, higher incidences of infection and malignancy were observed in the elderly.

• Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.

Dosage form specific issues:

• Maltose: Powder for injection may contain maltose, which may result in falsely-elevated serum glucose readings on the day of infusion.

Other warnings/precautions:

• Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B.

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.

Is abatacept available as a generic drug?

GENERIC AVAILABLE: No

How supplied

Storage And Handling

For Intravenous Infusion

ORENCIA® (abatacept) for Injection is a lyophilized powder for intravenous infusion after reconstitution and dilution. It is supplied as an individually packaged, single-use vial with a silicone-free disposable syringe, providing 250 mg of abatacept in a 15-mL vial:

NDC 0003-2187-10: in a clamshell presentation
NDC 0003-2187-13: in a carton presentation

For Subcutaneous Injection

ORENCIA® (abatacept) Injection and ORENCIA® ClickJect (abatacept) are solutions for subcutaneous administration.

Prefilled Syringe

ORENCIA Injection, 50 mg/0.4 mL, 87.5 mg/0.7 mL, and 125 mg/mL, is supplied as single-dose disposable prefilled glass syringes with BD UltraSafe Passive™ needle guard and flange extenders.

The Type I glass syringe has a coated stopper and fixed stainless steel needle (5 bevel, 29-gauge thin wall, ½-inch needle) covered with a rigid needle shield. The prefilled syringe provides abatacept in the following packages:

NDC 0003-2814-11 (50 mg/0.4 mL): pack of 4 syringes with a passive needle safety guard
NDC 0003-2818-11 (87.5 mg/0.7 mL): pack of 4 syringes with a passive needle safety guard
NDC 0003-2188-11 (125 mg/mL): pack of 4 syringes with a passive needle safety guard

ClickJect Autoinjector

ORENCIA ClickJect, 125 mg/mL, is supplied as a single-dose disposable prefilled autoinjector. The Type I glass syringe contained in the autoinjector has a coated stopper and fixed stainless steel needle (5 bevel, 27-gauge special thin wall, ½-inch needle) covered with a rigid needle shield. The autoinjector provides 125 mg of abatacept in 1 mL and is provided in the following package:

NDC 0003-2188-51: pack of 4 autoinjectors

Storage

ORENCIA lyophilized powder supplied in a vial should be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the vial. Protect the vials from light by storing in the original package until time of use.

ORENCIA solution supplied in a prefilled syringe or ClickJect autoinjector should be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the prefilled syringe or autoinjector. Protect from light by storing in the original package until time of use. Do not allow the prefilled syringe or autoinjector to freeze.

Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Revised March 2017

Patient information

ORENCIA®
(oh-REN-see-ah)
(abatacept) for Injection, for Intravenous Use

ORENCIA®
(oh-REN-see-ah)
(abatacept) Injection, for Subcutaneous Use

What is ORENCIA?

ORENCIA is a prescription medicine that reduces signs and symptoms in:

  • adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.
  • patients 2 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used alone or with methotrexate.
  • adults with active psoriatic arthritis (PsA). In adults, ORENCIA can be used alone or with other PsA treatments.

It is not known if ORENCIA is safe and effective in children under 2 years of age.

It is not known if ORENCIA is safe and effective in children for uses other than juvenile idiopathic arthritis.

Before you use ORENCIA, tell your healthcare provider about all of your medical conditions, including if you:

  • have any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu). If you have an infection when taking ORENCIA, you may have a higher chance for getting serious side effects.
  • have an infection that will not go away or an infection that keeps coming back.
  • are allergic to abatacept or any of the ingredients in ORENCIA. See the end of this Patient Information leaflet for a complete list of ingredients in ORENCIA.
  • have or have had inflammation of your liver due to an infection (viral hepatitis). Before you use ORENCIA, your healthcare provider may examine you for hepatitis.
  • have had a lung infection called tuberculosis (TB), a positive skin test for TB, or you recently have been in close contact with someone who has had TB. Before you use ORENCIA, your healthcare provider may examine you for TB or perform a skin test. Symptoms of TB may include:
    • a cough that does not go away
    • weight loss
    • fever
    • night sweats
  • are scheduled to have surgery.
  • recently received a vaccination or are scheduled for a vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not receive live vaccines.
  • have a history of a breathing problem called chronic obstructive pulmonary disease (COPD).
  • have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels. ORENCIA for intravenous infusion (given through a needle placed in a vein) contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of ORENCIA infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.
  • ORENCIA for subcutaneous injection (injected under the skin) does not contain maltose. You do not need to change your blood sugar monitoring if you are taking ORENCIA subcutaneously.
  • are pregnant or plan to become pregnant. It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.
    • Bristol-Myers Squibb Company has a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.
  • are breastfeeding or plan to breastfeed. It is not known if ORENCIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.

ORENCIA may affect the way other medicines work, and other medicines may affect the way ORENCIA works causing serious side effects.

Especially tell your healthcare provider if you take other biologic medicines to treat RA, JIA or PsA that may affect your immune system, such as:

  • Enbrel® (etanercept)
  • Humira® (adalimumab)
  • Remicade® (infliximab)
  • Kineret® (anakinra)
  • Rituxan® (rituximab)
  • Simponi® (golimumab)
  • Cimzia® (certolizumab pegol)
  • Actemra® (tocilizumab)

You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines for your RA, JIA, or PsA.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.

How should I use ORENCIA?

  • You may receive ORENCIA given by a healthcare provider through a vein in your arm (IV or intravenous infusion). It takes about 30 minutes to give you the full dose of medicine. You will then receive ORENCIA 2 weeks and 4 weeks after the first dose and then every 4 weeks.
  • You may also receive ORENCIA as an injection under your skin (subcutaneous). For home use, ORENCIA comes in a prefilled syringe or prefilled ClickJect autoinjector. Your healthcare provider will prescribe the type that is best for you. If your healthcare provider decides that you or a caregiver can give your injections of ORENCIA prefilled syringes or ORENCIA ClickJect autoinjectors at home, you or your caregiver should receive training on the right way to prepare and inject ORENCIA. Do not try to inject ORENCIA until you have been shown the right way to give the injections by your healthcare provider.
  • Your healthcare provider will tell you how much ORENCIA to use and when to use it.
  • See the Instructions for Use at the end of this Patient Information leaflet for instructions about the right way to prepare and give your ORENCIA injections at home.

What are the possible side effects of ORENCIA?

ORENCIA can cause serious side effects including:

  • infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections. Call your healthcare provider right away if you have any symptoms of an infection. Symptoms of an infection may include:
    • fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
    • hives
    • swollen face, eyelids, lips, or tongue
    • trouble breathing
  • hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start treatment with ORENCIA.
  • vaccinations. You should not receive ORENCIA with certain types of vaccines (live vaccines). ORENCIA may also cause some vaccinations to be less effective. Talk with your healthcare provider about your vaccination plans.
  • breathing problems in people with Chronic Obstructive Pulmonary Disease (COPD). Some people may get certain respiratory problems more often if they receive ORENCIA and have COPD. Symptoms of respiratory problems include:
    • COPD that becomes worse
    • cough
    • trouble breathing
  • cancer (malignancies). Certain kinds of cancer have been reported in people using ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects of ORENCIA include:

  •  headache
  • upper respiratory tract infection
  • throat
  • nausea

In children and adolescents, other side effects may include:

  • diarrhea
  • cough
  • fever
  • abdominal pain

These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

How should I store ORENCIA?

  • Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Keep ORENCIA in the original package and out of the light.
  • Do not freeze ORENCIA.
  • Safely throw away medicine that is out of date or no longer needed.

Keep ORENCIA and all medicines out of the reach of children.

General information about the safe and effective use of ORENCIA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ORENCIA for a condition for which it was not prescribed. Do not give ORENCIA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ORENCIA that is written for health professionals.

What are the ingredients in ORENCIA?

Active ingredient: abatacept

Intravenous inactive ingredients: maltose, monobasic sodium phosphate, sodium chloride for administration

Subcutaneous inactive ingredients: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, water for injection

INSTRUCTIONS FOR USE

ORENCIA®
(oh-REN-see-ah)
(abatacept)

Prefilled Syringe with BD UltraSafe Passive™ Needle Guard

ORENCIA® Prefilled Syringe with BD UltraSafe Passive™ Needle Guard (abatacept) Injection

Read these instructions before you start using your ORENCIA Prefilled Syringe and each time you get a refill. There may be new information. Before you use the prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it and decides that you or a caregiver may be able to give your injections of ORENCIA at home.

Important:

  • Keep the Prefilled Syringe in the refrigerator until ready to use.
  • Do not freeze.

Before You Begin: Get to Know Your Prefilled Syringe

There are 3 types of prefilled syringes:

The type of prefilled syringe you receive depends on the dose prescribed by your healthcare provider. The 125 mg/mL prefilled syringe is shown below.

The prefilled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection.

DO NOT remove the needle cover until you are ready to inject.

DONOT PULL back on the plunger at any time.

DO NOT RECAP the prefilled syringe at any time, as this may damage, bend, or break the needle.

Step 1: Preparing for an ORENCIA Injection

Gather and place supplies for your injection on a clean, flat surface.

Only the prefilled syringe is included in the package:

Let your Prefilled Syringe warm up.

Remove one prefilled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.

  • Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water.
  • Do not remove the needle cover while allowing the prefilled syringe to reach room temperature.

Wash your hands well with soap and water.

Step 2: Examine the Prefilled Syringe

Hold the prefilled syringe by the body with the needle cover pointing down as shown.

  • Check the expiration date printed on the label. Do not use if the expiration date has passed.
  • Check the prefilled syringe for damage. Do not use if it is cracked or broken.

Check the Liquid.

  • Check the liquid in the prefilled syringe through the viewing window. It should be clear and colorless to pale yellow.

Do not inject if the liquid is cloudy, discolored, or has particles in it.

*Note: the 50 mg prefilled syringe is shown.

Note: It is normal to see an air bubble. Do not attempt to remove it.

Step 3: Check the Dose on the Prefilled Syringe

Hold the syringe at eye level. Look closely to make sure that the amount of liquid in the prefilled syringe is at or just above the fill line for your prescribed dose:

Do not use if your prefilled syringe does not have the correct amount of liquid. Call your pharmacist immediately.

Step 4: Choose and Prepare an Injection Site

Choose your injection site.

Choose your injection site in either the stomach (abdomen), front of the thighs, or outer area of upper arm (only if caregiver administered).

Rotate injection site.

  • Each week you can use the same area of your body, but use a different injection site in that area.
  • Do not inject into an area where the skin is tender, bruised, red, scaly, or hard. Do not give the injection in any areas with scars or stretch marks.
  • Record the date, time, and site where you inject.

Gently clean injection site.

  • Wipe the injection site with an alcohol swab and let it air dry.
  • Do not touch the injection site again before giving the injection.
  • Do not fan or blow on the clean area.

Remove the needle cover by holding the body of the prefilled syringe with one hand and pulling the cover straight off with your other hand.

Do not put the needle cover back on the needle after you remove it. Throw away the needle cover in your household trash.

  • Do not use the prefilled syringe if it is dropped after the needle cover is removed.
  • Do not use the prefilled syringe if the needle is damaged or bent.

Note: It is normal to see a drop of fluid leaving the needle.

DO NOT RECAP the Prefilled Syringe, as this may damage the needle.

Step 5: Inject Your Dose of ORENCIA

Hold the body of the prefilled syringe in your hand using your thumb and index finger. With your other hand, pinch the area of skin you cleaned.

Insert the needle.

Gently insert the needle into the pinched skin at a 45° angle.

Complete all steps to deliver your full dose of the medicine.

Inject: push the plunger with your thumb as far as it will go.

Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard

Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click.

Remove the prefilled syringe and let go of the pinched skin.

Step 6: After the Injection

Care of injection site:

  • There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
  • Do not rub the injection site.
  • If needed, you may cover the injection site with an adhesive bandage.

Disposing of used Prefilled Syringes:

  • Put your used ORENCIA prefilled syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and prefilled syringes in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

See Frequently Asked Questions for additional disposal information.

If your injection is administered by a caregiver, this person must also be careful handling the syringe to prevent accidental needle stick injury and possibly spreading infection.

Keep ORENCIA prefilled syringes and the disposal container out of the reach of children.

How to store ORENCIA Prefilled Syringe

  • Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Keep ORENCIA in the original package and out of the light.
  • Do not freeze ORENCIA.
  • Safely throw away medicine that is out of date or no longer needed.

Frequently Asked Questions

Q. Why do I need to allow the prefilled syringe to warm up at room temperature for 30 minutes prior to injecting?

A. This step is primarily for your comfort. Never try to speed up the warming process in any way, like using the microwave or placing the syringe in warm water.

Q. Is it necessary to hold the skin pinch during the entire time I inject the dose?

A. You must pinch the skin during needle insertion however, for your comfort you may release the skin pinch as you deliver the injection.

Q. What if my prefilled syringe appears to be broken or damaged?

A. Do not use the prefilled syringe. Contact your healthcare provider or pharmacist for further instructions.

Q. What if I cannot clearly see the liquid inside the syringe?

A. Look at the syringe closely by holding at eye level and up to the light. You may tilt the syringe slowly to get a better view of the drug fluid. If you still have trouble, contact your healthcare provider or pharmacist for further instructions.

Q. Is it normal to feel a little bit of burning or pain during injection?

A. You may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. Discomfort should be mild to moderate. If you have any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider.

Frequently Asked Questions

Q. How should I dispose of a used prefilled syringe?

A. Place the used prefilled syringe into an FDA-cleared sharps disposal container. If you do not have one you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and injector pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

Q. How should I keep my prefilled syringes cool while traveling?

A. Store them in a cool carrier between 36°F to 46°F (2°C to 8°C). Do not freeze them. Keep them in the original carton and protected from light. Your healthcare provider may know about special carrying cases.

Q. Can I take my prefilled syringes on an airplane?

A. Generally you are allowed to carry your prefilled syringes with you on an airplane. Do not put them in your checked luggage. You should carry your prefilled syringes with you in your travel cooler at a temperature of 36°F to 46°F (2°C to 8°C). Keep your prefilled syringes in the original carton, and with its original preprinted labels and protected from light.

Q. What if my prefilled syringe does not stay cool for an extended period of time? Is it dangerous to use?

A. Contact 1-800-673-6242 for more information.

If you have questions or concerns about your prefilled syringe, please contact your healthcare provider or call our toll-free help line at 1-800-673-6242.

Bristol-Myers Squibb Company, Princeton, NJ 08543 USA, U.S. License Number 1713

INSTRUCTIONS FOR USE

ORENCIA® ClickJect™
(oh-REN-see-ah) (abatacept) Prefilled Autoinjector

ORENCIA® ClickJect™
(abatacept) Injection Prefilled Autoinjector

125 mg/mL, Single-Dose Autoinjector, For Subcutaneous Use Only

Read these instructions before you use the ClickJect Autoinjector and each time you get a refill. There may be new information. Before you use the Autoinjector for the first time, make sure your healthcare provider shows you the right way to use it.

Important:

  • Keep the ClickJect Autoinjector in the refrigerator until ready to use.
  • Do not freeze.

Before You Begin

Get to know the ClickJect Autoinjector

  • The Autoinjector automatically delivers the medicine. The transparent tip locks over the needle once the injection is complete and the Autoinjector is removed from the skin.
  • Do not remove the orange needle cover until you are ready to inject.

Gather supplies for your injection on a clean, flat surface (only the ClickJect Autoinjector is included in the package):

Step 1: Prepare Your Autoinjector

Let your ClickJect Autoinjector warm up.

Remove one Autoinjector from the refrigerator and let it rest at room temperature for 30 minutes.

Do not remove the Autoinjector needle cover while allowing it to reach room temperature.

Wash your hands well with soap and water.

Examine the ClickJect Autoinjector:

  • Check expiration date printed on the label. Do not use if past the expiration date.
  • Check the Autoinjector for damage. Do not use if it is cracked or broken.
  • Check the liquid through the viewing window. It should be clear and colorless to pale yellow. You may see a small air bubble. You do not need to remove it. Do not inject if the liquid is cloudy, discolored, or has particles in it.

Step 2: Prepare for Injection

Choose your injection site in either the stomach (abdomen), front of the thighs, or outer area of upper arm (only if caregiver administered).

Rotate injection site.

  • Each week you can use the same area of your body, but use a different injection site in that area.
  • Do not inject into an area where the skin is tender, bruised, red, scaly, or hard. Do not give the injection in any areas with scars or stretch marks.
  • Record the date, time, and site where you inject.

Gently clean injection site:

  • Wipe the injection site with an alcohol swab and let it air dry.
  • Do not touch the injection site again before giving the injection.
  • Do not fan or blow on the clean area.

Pull orange needle cover STRAIGHT off.

DO NOT RECAP the Autoinjector.

Throw away (discard) the needle cover in your household trash.

Do not use the Autoinjector if it is dropped after the needle cover is removed.

Note: It is normal to see a drop of fluid leaving the needle.

Step 3: Inject Your Dose

Position the Autoinjector so you can see the viewing window and it is at a 90° angle to the injection site. With your other hand, gently pinch the cleaned skin.

Complete all steps to deliver your full dose of medicine:

Push DOWN on the skin to unlock the Autoinjector.

Press button, HOLD for 15 seconds AND watch window.

  • You will hear a click as the injection begins.
  • To deliver the full dose of medicine, hold the Autoinjector in place for 15 seconds AND wait until the blue indicator stops moving in window.

Remove the ClickJect Autoinjector from the injection site by lifting it straight up. After you remove it from your skin, the transparent tip will lock over the needle. Release skin pinch.

Step 4: After the Injection

Care of injection site:

  • There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
  • Do not rub the injection site.
  • If needed, you may cover the injection site with an adhesive bandage.

Disposing of used ClickJect Autoinjectors:

  • Put your used ClickJect Autoinjector in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and prefilled syringes in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

See Frequently Asked Questions for additional disposal information.

If your injection is administered by a caregiver, this person must also handle the Autoinjector carefully to prevent accidental needle stick injury and possibly spreading infection.

Keep Autoinjector and the disposal container out of the reach of children.

How to store ORENCIA ClickJect Autoinjector

  • Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Keep ORENCIA in the original package and out of the light.
  • Do not freeze ORENCIA.
  • Safely throw away medicine that is out of date or no longer needed

Frequently Asked Questions

Q. Why do I need to allow the Autoinjector to warm up at room temperature for 30 minutes prior to injecting?

A. This step is primarily for your comfort. If the medicine is cold, the injection may take longer than 15 seconds. Never try to speed the warming process in any way, like using the microwave or placing the Autoinjector in warm water.

Q. What if I accidentally remove the needle cover (orange cap) before I'm ready to use the Autoinjector?

A. If you remove the cover before you are ready to use the Autoinjector, be careful. Do not try to replace it. Use the Autoinjector as soon as possible. While you prepare for the injection, carefully place the Autoinjector on its side on a clean, flat surface. Be sure to keep the Autoinjector away from children.

Q. What if the Autoinjector appears to be broken or damaged?

A. Do not use the Autoinjector. Contact your healthcare provider or pharmacist for further instructions.

Q. What if the injection was not triggered?

A. Before the injection can be triggered, the device must be unlocked. To unlock, firmly push the Autoinjector down on the skin without touching the button. Once the stop-point is felt, the device is unlocked and can be triggered by pushing the button.

Q. I feel a little bit of burning or pain during injection. Is this normal?

A. When giving an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. If this occurs, the discomfort should be mild to moderate. If you experience any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider or pharmacist immediately. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Q. How do I know I received my full dose?

A. Before lifting the Autoinjector from the injection site, check to ensure that the blue indicator has stopped moving. Then, before disposing of the Autoinjector, check the bottom of the transparent viewing window to make sure there is no liquid left inside. If the medicine has not been completely injected, consult your healthcare provider or pharmacist.

Frequently Asked Questions

Q. How should I dispose of a used Autoinjector?

A. Place used Autoinjector into an FDA-cleared sharps disposal container right away after use.

  • If you do not have one, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not recycle your used sharps disposal container.

Q. How should I keep my Autoinjector cool while traveling?

A. Your healthcare provider or pharmacist may be familiar with special carrying cases for injectable medicines. Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light.

Q. Can I take my Autoinjector on board an aircraft?

A. Generally, this is allowed. Be sure to pack your Autoinjector in your carry-on, and do not put it in your checked luggage. You should carry it with you in your travel cooler at a temperature of 36°F to 46°F (2°C to 8°C) until you are ready to use it. Airport security procedures and airline policies change from time to time, so it's best to check with airport authorities and the airline for any special rules. Prior to flying, get a letter from your healthcare provider to explain that you are traveling with prescription medicine that uses a device with a needle; if you are carrying a sharps container in your carry-on baggage, notify the screener at the airport.

Q. What if my Autoinjector does not stay cool for an extended period of time? Is it dangerous to use?

A. Contact 1-800-673-6242 for details.

If you have questions or concerns about your Autoinjector, please contact a healthcare provider or call our toll-free help line at 1-800-673-6242.

Abatacept Interactions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Abatacept may affect the way other medicines work, and other medicines may affect the way abatacept works causing serious side effects.

Especially tell your healthcare provider if you take other biologic medicines that may affect your immune system, such as:

  • Enbrel (etanercept)
  • Humira (adalimumab)
  • Remicade (infliximab)
  • Kineret (anakinra)
  • Rituxan (rituximab)
  • Simponi (golimumab)
  • Cimzia (certolizumab pegol)
  • Actemra (tocilizumab)

You may have a higher chance of getting a serious infection if you take abatacept with other biologic medicines. 

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.

Renal Dose Adjustments

Data not available

Other Comments

Administration advice:
IV infusion:
-Infuse over 30 minutes via an infusion set and a sterile, non-pyrogenic, low-protein binding filter with a pore size of 0.2 to 1.2 microns.
Subcutaneous administration:
-Subcutaneous administration is only indicated for adults.
-The first dose should be given under medical supervision. Patients can then self-inject after the treating physician is assured that the patient or caregiver's injection technique is satisfactory.
-Injection sites should be rotated and not administered into tender, bruised, red, or hard areas of skin.

Monitoring:
-When transitioning from TNF blocking agents to this drug, patients should be monitored for signs of infection.
-Patients who develop a new infection while undergoing treatment should be monitored closely and treatment discontinued if a patient develops a serious infection.
-Adult patients with rheumatoid arthritis and COPD should be monitored for worsening of respiratory status.
-Patients should be monitored for hypersensitivity reactions before and after administration.

General:
-This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Administrative Information

LactMed Record Number

893

Last Revision Date

20160426

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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