Adalimumab-atto Subcutaneous

Name: Adalimumab-atto Subcutaneous

Commonly used brand name(s)

In the U.S.

  • Amjevita

Available Dosage Forms:

  • Solution

Therapeutic Class: Antirheumatic

Pharmacologic Class: Adalimumab

Uses For adalimumab-atto

Adalimumab-atto injection is used to treat the symptoms and prevent the progression of moderate to severely active rheumatoid arthritis and ankylosing spondylitis. It is used in children 4 years of age and older for juvenile idiopathic arthritis. adalimumab-atto is also used to treat psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body. Psoriatic arthritis usually occurs with a skin condition called psoriasis. Adalimumab-atto may be used alone or in combination with medicines (eg, methotrexate).

Adalimumab-atto injection is also used to treat the symptoms of active Crohn’s disease in patients who have not been helped by other medicines (eg, infliximab). It is also used to treat moderate to severe ulcerative colitis in patients who have been treated with other medicines (eg, azathioprine, corticosteroids, or 6-mercaptopurine) that did not work well. adalimumab-atto may also be used to treat moderate to severe chronic plaque psoriasis, which is a skin disease with red patches and white scales that don’t go away.

adalimumab-atto is available only with your doctor’s prescription.

Before Using adalimumab-atto

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For adalimumab-atto, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to adalimumab-atto or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of adalimumab-atto injection for the treatment of juvenile idiopathic arthritis in children 4 to 17 years of age. However, safety and efficacy have not been established in children younger than 4 years of age for juvenile idiopathic arthritis, and safety and efficacy have not been established for other uses in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adalimumab-atto injection in the elderly. However, adalimumab-atto may cause serious infections and cancer more often in the elderly, which may require caution in patients receiving adalimumab-atto injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking adalimumab-atto, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using adalimumab-atto with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Adenovirus Vaccine
  • Anakinra
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rilonacept
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of adalimumab-atto. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood problems (eg, aplastic anemia, pancytopenia, thrombocytopenia), history of or
  • Congestive heart failure or
  • Guillain-Barré syndrome, history of or
  • Infections (fungal, bacterial), history of or
  • Leukopenia (low number of white blood cells) or
  • Multiple sclerosis or
  • Optic neuritis (eye problem) or
  • Psoriasis (skin disease)—Use with caution. May make these conditions worse.
  • Cancer, active or history of or
  • Chronic obstructive pulmonary disease (COPD) or
  • Wegener’s granulomatosis—Use with caution. May increase the chance of getting new cancers.
  • Diabetes or
  • Hepatitis B, history of or
  • Opportunistic infections, history of or
  • Tuberculosis, history of—May increase chance for side effects.
  • Infection, active—Should not be used in patients with this condition.
  • Tuberculosis, active—Should be treated first before receiving adalimumab-atto.

Proper Use of adalimumab-atto

adalimumab-atto is given as a shot under your skin. Adalimumab-atto may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using adalimumab-atto at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

adalimumab-atto comes with a Medication Guide and patient Instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use adalimumab-atto at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

adalimumab-atto is available in 2 forms. You may use a prefilled SureClick® autoinjector or a prefilled syringe.

To use the autoinjector or syringe:

  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Wash your hands with soap and water before and after using adalimumab-atto.
  • Remove the carton with the syringe or pen from the refrigerator and place it on the cloth.
  • Allow 15 to 30 minutes for the syringe or autoinjector to warm up to room temperature. Do not warm adalimumab-atto in any other way.
  • Do not remove the needle cover on the prefilled syringe or autoinjector while allowing the medicine to reach room temperature. Remove these immediately before use.
  • Check the liquid in the syringe or autoinjector using the viewing window. It should be clear and colorless. If it is cloudy, discolored, or has particles floating in it, do not use the syringe or autoinjector.
  • Check that the amount of liquid in the autoinjector is the same or close to the fill line seen on the window. The fill line shows a full dose of the medicine. If the autoinjector does not have the full amount of liquid, do not use it. Call your pharmacist. If the liquid is clear, place it on a clean, flat surface. Do not shake the medicine.
  • Check the expiration date on the prefilled syringe or autoinjector, and make sure the date has not passed. Do not use the medicine if the date has passed.
  • Choose an injection site on your body (eg, thigh, abdomen or stomach area). Clean the injection site with a fresh alcohol wipe and let it dry.
  • Remove the cap or needle cover when you are ready to inject. Inject the full amount of medicine within a few minutes after the cap or cover has been removed.
  • Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
  • Do not inject into skin areas that are red, bruised, tender, or hard. If you have psoriasis, do not inject into a raised, thick, red, or scaly skin patch or into skin lesions.
  • You might have a small amount of blood or liquid at the injection site. Press and hold a dry, clean cotton ball on the injection site for 10 seconds, but do not rub it.
  • Throw away used syringes or autoinjector in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Dosing

The dose of adalimumab-atto will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of adalimumab-atto. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage forms (autoinjector or prefilled syringe):
    • For Crohn’s disease:
      • Adults—At first (week 0), 160 milligrams (mg) injected under the skin in divided doses. This may be given as four shots in 1 day or as two shots per day for 2 days. Then 2 weeks later, a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.
    • For juvenile idiopathic arthritis:
      • Children 4 to 17 years of age weighing 30 kilograms (kg) or more—40 milligrams (mg) injected under the skin every other week.
      • Children 4 to 17 years of age weighing between 15 to less than 30 kg—20 mg injected under the skin every other week.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For plaque psoriasis:
      • Adults—At first, 80 milligrams (mg) injected under the skin, then 40 mg 1 week after the initial dose and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.
    • For psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis:
      • Adults—40 milligrams (mg) injected under the skin every other week. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For ulcerative colitis:
      • Adults—At first (week 0), 160 milligrams (mg) injected under the skin in divided doses. This may be given as four shots in 1 day or as two shots per day for 2 days. Then 2 weeks later, a dose of 80 mg is given. A maintenance dose of 40 mg is given at week 4 and every other week thereafter.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of adalimumab-atto, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep your medicine and supplies in the original packages until you are ready to use them. Also, when traveling, store the medicine in a cool carrier with an ice pack or store at room temperature for up to 14 days.

adalimumab-atto Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cough
  • diarrhea
  • difficulty with breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • shivering
  • sneezing
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness of the chest or trouble breathing
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common
  • Abdominal or stomach pain
  • bleeding from the gums or nose
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain
  • dizziness
  • eye pain
  • fainting
  • fast, slow, or irregular heartbeat
  • general feeling of tiredness or weakness
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • rapid weight gain
  • ringing in the ears
  • sores, ulcers, or white spots on the lips or in the mouth
  • tingling of the hands or feet
  • unusual bleeding or bruising
  • unusual weight gain or loss
Incidence not known
  • Blindness
  • blistering, peeling, loosening of the skin
  • blue-yellow color blindness
  • blurred vision
  • dark-colored urine
  • decreased vision
  • diarrhea
  • eye pain
  • general feeling of tiredness or weakness
  • itching
  • joint or muscle pain
  • light-colored stools
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, scaling, or crusted skin
  • stomach pain, continuing
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • rash
Incidence not known
  • Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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