Doravirine

Doravirine is a prescription medication indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in patients:

• without prior antiretroviral therapy (ART) treatment history
• to replace the current ART regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ART regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Doravirine is available under the following different brand names: Pifeltro

Common side effects of Doravirine include:

• nausea
• dizziness
• headache
• fatigue
• diarrhea
• abdominal pain
• abnormal dreams
• insomnia

Serious side effects of Doravirine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• night sweats
• swollen glands
• cold sores
• cough
• wheezing
• diarrhea
• weight loss
• trouble speaking or swallowing
• problems with balance or eye movement
• weakness
• prickly feeling
• swelling in neck or throat (enlarged thyroid)
• menstrual changes
• impotence

Rare side effects of Doravirine 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 as a result 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

HIV Infection

Adult dosage

• 100 mg orally every day

Pediatric dosage

• Children older than 12 years and weighing more than 35 kg: 100 mg orally every day

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, healthcare provider, or pharmacist first.

• Doravirine has severe interactions with at least 33 drugs.
• Doravirine has serious interactions with the following drugs:
  • betibeglogene autotemcel
  • cabotegravir
  • elivaldogene autotemcel
  • fexinidazole
  • tucatinib
  • voxelotor
• Doravirine has moderate interactions with at least 34 drugs.
• Doravirine has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • ketoconazole
  • larotrectinib
  • levoketoconazole
  • ribociclib

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 of all the products you use. 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, or if you have health questions, concerns.

Contraindications

• Strong CYP3A4 inducers
  • Coadministered with strong CYP3A inducers, as significant decreases in doravirine plasma concentrations may occur, which may decrease the efficacy of doravirine
  • Strong CYP3A inducer examples include carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, and St. John's wort

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Doravirine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Doravirine?"

Cautions

• Immune reconstitution syndrome reported in patients treated with combination ART; patients may develop an inflammatory response to indolent or residual opportunistic infections (such as mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis, which may necessitate further evaluation and treatment
• Autoimmune disorders (eg, Grave's 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
  • Primarily metabolized by CYP3A; drugs that induce or inhibit CYP3A may affect doravirine clearance
  • Coadministration with strong CYP3A inducers may decrease systemic exposure and lead to loss of therapeutic effect and possible HIV resistance

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 to doravirine during pregnancy
• Data are not available to establish drug-associated risks to pregnancy outcomes
• Lactation
  • The CDC does not recommend HIV-infected women breastfeed their infants owing to the potential risk for postnatal transmission of HIV
  • Unknown if distributed in human breast milk
  • Owing to the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant similar to those seen in adults, instruct women not to breastfeed while taking this medication