Bulevirtide-gmod Injection

Once you stop taking this medication, your hepatitis D or hepatitis B virus infection may suddenly get much worse, especially in people with cirrhosis (serious liver damage or scarring). If you stop taking this medicine, your doctor will closely monitor your liver health with checkups and blood tests, including tests that measure hepatitis B and hepatitis D virus levels, for at least 6 months. In some cases, you may need to start treatment again.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to bulevirtide-gmod.

Talk to your doctor about the risks of taking bulevirtide-gmod.

Bulevirtide-gmod injection is used to treat certain cases of chronic (long-lasting) hepatitis delta virus (HDV; a viral infection of the liver) infection. Bulevirtide-gmod is in a class of medications called antivirals. It works by decreasing the amount of HDV in the body.

Bulevirtide-gmod injection comes as a powder to be mixed with liquid to be given subcutaneously (under the skin). It is given once a day. Your doctor will determine how long you should be using it.

Use bulevirtide-gmod injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully.Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Use only the water that comes with it to mix with the powder. After mixing, make sure the solution is free of particles and is clear and colorless. Bulevirtide-gmod injection can be given in the thigh or abdomen. If a caregiver is giving you the injection, the back of the arm may be used.

Bulevirtide-gmod controls HDV but does not cure it. Do not stop using bulevirtide-gmod injection without talking to your doctor. If you suddenly stop using bulevirtide-gmod injection, your hepatitis D or hepatitis B infection may become worse.

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

Before using bulevirtide-gmod injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using bulevirtide-gmod injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Bulevirtide-gmod injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, bruising, pain, or swelling at the site of injection
• headache
• stomach pain
• tiredness
• itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• itching, hives; difficulty breathing or swallowing; swelling of the face, eyes, lips, or mouth

Bulevirtide-gmod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). After adding water to the powder, inject the contents immediately. Do not store for later use.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will may order certain lab tests to check your body's response to bulevirtide-gmod.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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