Abacavir, dolutegravir, and lamivudine

Name: Abacavir, dolutegravir, and lamivudine

How should I take Triumeq?

Follow all directions on your Triumeq prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take Triumeq with or without food.

Triumeq comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Carry this Warning Card with you at all times so you will know what symptoms to watch for.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

While using Triumeq, you may need frequent blood tests.

If you have ever had hepatitis B, this condition may come back or get worse during treatment or after you stop taking Triumeq. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away. Do not take extra medicine to make up the missed dose. Get your prescription refilled before you run out of medicine completely.

Triumeq side effects

Stop using Triumeq and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

  • Group 1 - fever;

  • Group 2 - rash;

  • Group 3 - nausea, vomiting, diarrhea, stomach pain;

  • Group 4 - general ill feeling, extreme tiredness, body aches;

  • Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to a medicine that contains abacavir or dolutegravir, you must never use it again. If you stop taking Triumeq for any reason, talk to your doctor before you start taking it again.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have other serious side effects:

  • liver problems--nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Triumeq may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Triumeq. Tell your doctor if you have:

  • fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • headache, sleep problems (insomnia), tired feeling; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

  • Triumeq

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Contraindications

Hypersensitivity to abacavir, dolutegravir, lamivudine, or any component of the formulation; patients with HLA-B*5701 allele; concomitant dofetilide; moderate or severe hepatic impairment

Dosing Adult

HIV treatment: Oral: One tablet daily

Dosage adjustment for concomitant therapy: With efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin: One tablet daily, with an additional dolutegravir 50 mg tablet daily administered 12 hours after Triumeq

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, insomnia, or loss of strength and energy. Have patient report immediately to prescriber signs of allergic reaction with organ failure (fever, rash, fatigue, flu-like signs, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, cough, or difficulty breathing), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe dizziness, passing out, angina, mouth sores, eye pain/strain, muscle pain, joint pain, burning or numbness feeling, edema, change in body fat, shortness of breath, enlarged lymph nodes, or signs of infection (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with medication to absorb moisture) from your bottle.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of abacavir, dolutegravir, and lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Use: For the treatment of HIV-1 infection

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