Doravirine-Lamivudine-Tenofovir DF

Doravirine-Lamivudine-Tenofovir DF is a combination medication used for the treatment of HIV-1 infection in patients without prior antiretroviral therapy (ART) treatment history, OR

To replace current ART regimen in those who are virologically suppressed (HIV-1 RNA below 50 copies/mL) on a stable ART regimen with no history of treatment failure and no known substitutions associated with resistance to the individual drug components. 

• Doravirine-Lamivudine-Tenofovir DF is available under the following different brand names: Delstrigo.

Common side effects of Doravirine-Lamivudine-Tenofovir DF include:

• Nausea,
• Dizziness, and
• Strange dreams

Serious side effects of Doravirine-Lamivudine-Tenofovir DF include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Urinating more or less than usual,
• Increased thirst,
• New or worsening bone pain,
• Muscle pain,
• Weakness,
• Pain in the arms, legs, hands, or feet,
• Fever,
• Night sweats,
• Swollen glands,
• Cold sores,
• Cough,
• Wheezing,
• Diarrhea,
• Weight loss,
• Trouble speaking or swallowing,
• Problems with balance or eye movement,
• Weakness or prickly feeling,
• Swelling in the neck or throat (enlarged thyroid),
• Menstrual changes, and
• Impotence

Rare side effects of Doravirine-Lamivudine-Tenofovir DF include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 100 mg/300 mg/300 mg

HIV Infection

Adult dosage

• 1 tablet (100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir DF) orally once a day with or without food

Pediatric dosage

• Children aged 12 years and older and weighing 35 years and above:
• 1 tablet (100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir DF) orally once a day with or without food

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Doravirine-Lamivudine-Tenofovir DF has severe interactions with at least 36 other drugs.
• Doravirine-Lamivudine-Tenofovir DF has serious interactions with at least 21 other drugs.
• Doravirine-Lamivudine-Tenofovir DF has moderate interactions with at least 155 other drugs.
• Doravirine-Lamivudine-Tenofovir DF has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • black cohosh
  • cyclophosphamide
  • isavuconazonium sulfate
  • ketoconazole
  • larotrectinib
  • levoketoconazole
  • paromomycin
  • ribociclib
  • sulfamethoxazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to lamivudine
• Strong CYP3A inducers
• Doravirine is contraindicated with strong CYP3A inducers, which may decrease effectiveness.
• Strong CYP3A inducer examples
• Anticonvulsants (. g, carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
• Antimycobacterial (. g, rifampin, rifapentine)
• Enzalutamide
• Mitotane
• St. John’s wort (Hypericum perforatum)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Doravirine-Lamivudine-Tenofovir DF?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Doravirine-Lamivudine-Tenofovir DF?”

Cautions

• Severe acute exacerbations of hepatitis B (. g, liver decompensated, liver failure) reported in patients coinfected with HIV-1 and HBV and who have discontinued products containing lamivudine and/or tenofovir DF.
• Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with tenofovir DF; avoid concurrent or recent use of nephrotoxic agents (. g, high-dose or multiple NSAIDs)
• Discontinue if CrCl declines below 50 mL/min.
• Tenofovir DF is associated with decreased bone mineral density (BMD) and increased biochemical markers of bone metabolism; consider assessing BMD in patients at risk.
• Immune reconstitution syndrome reported with combination ART.
• Autoimmune disorders (. g, Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) reported to occur in the setting of immune reconstitution; however, time to onset varies and can occur many months after initiation of treatment.
• Drug interaction overview
  • Coadministration of doravirine with strong CYP3A inducers may decrease systemic exposure and lead to loss of therapeutic effect and possible HIV resistance.
  • Since Delstrigo is a complete regimen for HIV-1 infection, coadministration with other antiretroviral medications for HIV-1 infection is not recommended; information regarding potential drug-drug interactions with other antiretroviral medications is not provided.

Pregnancy and Lactation

• Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263; the pregnancy exposure registry monitors pregnancy outcomes in individuals exposed during pregnancy.
• Data are not available to establish drug-associated risks to pregnancy outcomes.
• Doravirine has not been evaluated in pregnancy; however, lamivudine and tenofovir DF use during pregnancy has been evaluated in a limited number of individuals reported to the APR; available data from the APR show no difference in the overall risk of major birth defects for lamivudine and TDF compared with the background rate for major birth defects of 2.7% in the US reference population.
• Lactation
  • The Centers for Disease Control and Prevention do not recommend HIV-infected women breastfeed their infants, owing to the potential risk for postnatal transmission of HIV.