Delstrigo

Delstrigo is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who have not taken HIV-1 medicines before. It is a single product containing 3 medications: doravirine, lamivudine, and tenofovir disoproxil fumarate.

Delstrigo belongs to a group of drugs called antiretrovirals, more specifically non-nucleoside reverse transcriptase inhibitors (NNRTI) as well as nucleoside analogue reverse transcriptase inhibitors (NRTIs). These help to block essential enzymes needed by HIV to make copies of itself.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects of Delstrigo include nausea, and abnormal dreams. Delstrigo can also cause dizziness. Do not drive or operate heavy machinery until you know how Delstrigo affects you.

Delstrigo is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who have not taken HIV-1 medicines before.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Delstrigo contains the prescription medicines doravirine, lamivudine and tenofovir disoproxil fumarate.

It is not known if Delstrigo is safe and effective in children under 18 years of age.

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

Serious side effects have been reported with Delstrigo. See the “Delstrigo Precautions” section.

Common side effects of Delstrigo include the following:

• Dizziness

• Nausea

• Abnormal dreams

Tell your doctor if you have any of the following symptoms during treatment with Delstrigo: bone pain that does not go away or worsening bone pain, pain in your arms, legs, hands or feet, broken (fractured) bones or muscle pain or weakness. These may be symptoms of a bone or kidney problem.

This is not a complete list of Delstrigo side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Androgen receptors such as Xtandi (enzalutamide)

• Anticonvulsants such as Tegetrol (carbamazepine), Trileptal (oxcarbazepine), Luminal/Solfoton (phenobarbital), and Dilantin (phenytoin)

• Antimycobacterial such as Rifadin (rifampin), Priftin (rifapentine), and Mycobutin (rifabutin)

• Cytotoxic agents such as Lysodren (mitotane)

• Hepatitis C antiviral agents such as Harvoni (ledipasivir/sofobuvir) and Epclusa (sofobuvir/velpatasvir)

• Herbal products such as St. John’s wort

• Sorbitol

This is not a complete list of Delstrigo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Delstrigo including the following:

• Worsening of hepatitis B virus infection (HBV). If you have HBV infection and take Delstrigo, your HBV infection may get worse (flare-up) if you stop taking Delstrigo. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your doctor will test you for HBV infection before you start treatment with Delstrigo.
  • Do not run out of Delstrigo. Refill your prescription or talk to your doctor before your Delstrigo is all gone.
  • Do not stop taking Delstrigo without first talking to your doctor.
  • If you stop taking Delstrigo, your doctor will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your doctor about any new or unusual symptoms you may have after you stop taking Delstrigo.

• New or worse kidney problems, including kidney failure. Your doctor should do blood and urine tests to check your kidneys before you start and during treatment with Delstrigo. Your doctor may tell you to stop taking Delstrigo if you develop new or worse kidney problems.

• Bone problems can happen in some people who take Delstrigo. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your doctor may need to do tests to check your bones.

  Tell your doctor if you have any of the following symptoms during treatment with Delstrigo: bone pain that does not go away or worsening bone pain, pain in your arms, legs, hands or feet, broken (fractured) bones or muscle pain or weakness. These may be symptoms of a bone or kidney problem.

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV-1 medicine.

• Delstrigo can cause dizziness. Do not drive or operate heavy machinery until you know how Delstrigo affects you.

Do not take Delstrigo if you:

• Have a previous hypersensitivity reaction to lamivudine or any of Delstrigo’s ingredients

• Take any of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John’s wort

Medications can interact with certain foods. In some cases, this may be harmful, and your doctor may advise you to avoid certain foods. In the case of Delstrigo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Delstrigo, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have hepatitis B virus infection
• have kidney problems
• have bone problems, including a history of bone fractures
• are pregnant or plan to become pregnant. It is not known if Delstrigo can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Delstrigo.

Pregnancy Registry: There is a pregnancy registry for people who take Delstrigo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Delstrigo.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • Two of the medicines in Delstrigo (lamivudine and tenofovir) can pass into your breast milk. It is not known if doravirine can pass into your breast milk. Talk with your doctor about the best way to feed your baby.

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

• Some medicines interact with Delstrigo. Keep a list of your medicines to show your doctor and pharmacist.
• Tell your doctor if you have taken rifabutin in the past 4 weeks.
• You can ask your doctor or pharmacist for a list of medicines that interact with Delstrigo.
• Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Delstrigo with other medicines.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Delstrigo. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

• It is not known if Delstrigo can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Delstrigo.

• Pregnancy Registry: There is a pregnancy registry for people who take Delstrigo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Do not breastfeed if you take Delstrigo.

• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
• Two of the medicines in Delstrigo (lamivudine and tenofovir) can pass into your breast milk. It is not known if doravirine can pass into your breast milk.
• Talk with your doctor about the best way to feed your baby.

• Take Delstrigo every day exactly as your doctor tells you to take it.

• Take Delstrigo 1 time each day, at about the same time every day.

• Delstrigo is usually taken by itself (without other HIV-1 medicines). If you take the medicine rifabutin during treatment with Delstrigo, your doctor will also prescribe an additional dose of doravirine for you. You may not have enough doravirine in your blood if you take rifabutin during treatment with Delstrigo. Carefully follow your doctor’s instructions about when to take doravirine and how much to take. This is usually 1 tablet of doravirine about 12 hours after your last dose of Delstrigo.

• Take Delstrigo with or without food.

• Do not change your dose or stop taking Delstrigo without talking to your doctor. Stay under a doctor’s care when taking Delstrigo.

• It is important that you do not miss or skip doses of Delstrigo.

• If you miss a dose of Delstrigo, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Delstrigo at the same time.

• If you have any questions, call your doctor or pharmacist.

• If you take too much Delstrigo, call your doctor or go to the nearest hospital emergency room right away.

• When your Delstrigo supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Delstrigo and become harder to treat.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose the doctor recommends may be based on the following:

• The condition being treated

• Other medical conditions you have

• Other medications you are taking

The recommended dose of Delstrigo as a complete regimen for the treatment of HIV-1 infection and hepatitis B symptoms in adults is one tablet (100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate) taken orally once daily with or without food.

• Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute.

• Dosage adjustment with rifabutin: Take one tablet of Delstrigo once daily, followed by one tablet of doravirine 100 mg (Pifeltro) approximately 12 hours after the dose of Delstrigo.

If you take too much Delstrigo call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Delstrigo tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Delstrigo in the original bottle.
• Do not take the tablets out of the bottle to store in another container, such as a pill box.
• Keep the bottle tightly closed to protect Delstrigo from moisture.
• The Delstrigo bottle contains desiccants to help keep your medicine dry (protect it from moisture). Keep the desiccants in the bottle. Do not eat the desiccants.

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

This page was written by Kevin Gian, PharmD Candidate 2020 | UT Austin College of Pharmacy

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DELSTRIGO. If appropriate, initiation of anti-hepatitis B therapy may be warranted.