Doravirine

WHY is this medicine prescribed?

Doravirine is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults who have not been treated with other HIV medications. It is also used to replace current medication therapy in certain people already taking HIV medications. Doravirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although doravirine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Doravirine comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take doravirine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doravirine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Doravirine helps to control HIV infection but does not cure it. Continue to take doravirine even if you feel well. Do not stop taking doravirine without talking to your doctor. If you stop taking doravirine or miss doses, your condition may become more difficult to treat. When your supply of doravirine starts to run low, get more from your doctor or pharmacist.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking doravirine,

• tell your doctor and pharmacist if you are allergic to doravirine, any other medications, or any of the ingredients in doravirine tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), enzalutamide (Xtandi), mitotane (Lysodren), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rifapentine (Priftin), or St. John's wort. Your doctor will probably tell you not to take doravirine if you are currently taking one or more of these medications or have taken one of them within the past 4 weeks.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: efavirenz (Sustiva, in Atripla), etravirine (Intelence), or nevirapine (Viramune). Also, tell your doctor if are taking rifabutin (Mycobutin) or have taken it within the past 4 weeks. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with doravirine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection) or an autoimmune disease (conditions that develop when the immune system attacks healthy cells in the body by mistake) such as Graves' disease (condition where the body attacks the thyroid gland causing it to be overactive), polymyositis (condition that causes muscle weakness but not skin rash), Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage), and autoimmune hepatitis (condition in which the cells of the immune system attack the liver).

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking doravirine, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking doravirine.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with doravirine be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take 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 take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• headache
• tiredness
• stomach pain
• abnormal dreams
• difficulty falling asleep or staying asleep
• dizziness

Doravirine 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 store the tablets in a pillbox or pill-organizer. Do not remove the desiccant (drying agent) from the bottle.

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

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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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

Keep a supply of doravirine on hand. Do not wait until you run out of medication to refill your prescription.

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