Loading

Please wait...

Pifeltro

Generic Name: doravirine (DOR a VIR een)
Brand Names: Pifeltro
Pifeltro (doravirine) is used to treat HIV-1 infection. Includes Pifeltro side effects, interactions and indications.
  • Prescription Settings

Prices and coupons of Pifeltro

Current Location: 20149 (Ashburn)
Change Location?

Enter your zip code


Please wait while the prices are loaded...

Don’t see your pharmacy listed? Most pharmacies accept our discounts, so have your pharmacist enter this coupon to see if you will save money:

Drug Information:
Pifeltro (doravirine) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Pifeltro is used together with other medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Pifeltro is not a cure for HIV or AIDS. Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with Pifeltro, and some drugs should not be used together. Get emergency medical help if you have signs of an allergic reaction to Pifeltro: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Learn more

Pifeltro Side Effects

Pifeltro Side Effects

Note: This document contains side effect information about doravirine. Some of the dosage forms listed on this page may not apply to the brand name Pifeltro.

For the Consumer

Applies to doravirine: oral tablet

Along with its needed effects, doravirine (the active ingredient contained in Pifeltro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of doravirine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Headache
  • nausea
  • unusual tiredness or weakness

Less common

  • Abnormal dreams
  • diarrhea
  • dizziness
  • skin rash
  • stomach pain
  • trouble sleeping

For Healthcare Professionals

Applies to doravirine: oral tablet

General

The safety of this drug was assessed in 2 Phase 3 trials, as a single component in combination with emtricitabine-tenofovir disoproxil fumarate (DF) or abacavir-lamivudine and as a component of the fixed-dose combination drug (doravirine (the active ingredient contained in Pifeltro) emtricitabine/tenofovir DF). Most (72%) side effects associated with this drug were of mild severity (grade 1).

Unless otherwise specified, the side effects provided below were reported during the trial using this drug (as a single component) in combination with emtricitabine-tenofovir DF or abacavir-lamivudine.

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, abdominal pain (included abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, epigastric discomfort), increased lipase

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Common (1% to 10%): Nausea, diarrhea, increased lipase

-Uncommon (0.1% to 1%): Abdominal pain

Increased lipase (1.5 to less than 3 times the upper limit of normal [1.5 to less than 3 x ULN]: 4%; at least 3 x ULN: 3%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).

Nervous system

Common (1% to 10%): Headache, dizziness

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Common (1% to 10%): Dizziness, headache, altered sensorium (included altered state of consciousness, lethargy, somnolence, syncope), somnolence

Other

Increased alkaline phosphatase (2.5 to less than 5 x ULN), fasted LDL cholesterol (at least 190 mg/dL), and fasted triglycerides (greater than 500 mg/dL) have each been reported in less than 1% of patients using this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).

Fasting lipids changed from baseline to week 48; changes included increased HDL cholesterol and reduced LDL cholesterol, non-HDL cholesterol, total cholesterol, and triglycerides.

Common (1% to 10%): Fatigue (included fatigue, asthenia, malaise)

Frequency not reported: Increased alkaline phosphatase, increased fasted low-density lipoprotein (LDL) cholesterol, increased fasted triglycerides, fasting lipids changed from baseline (including LDL cholesterol, non-high-density lipoprotein [HDL] cholesterol, total cholesterol, triglycerides, HDL cholesterol)

Doravirine/lamivudine/tenofovir DF:

-Common (1% to 10%): Fatigue

-Frequency not reported: Increased fasted cholesterol, increased fasted LDL cholesterol, increased fasted triglycerides, fasting lipids changed from baseline

Hepatic

Common (1% to 10%): Increased total bilirubin, increased AST, increased ALT

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Common (1% to 10%): Increased total bilirubin, increased ALT, increased AST

Increased total bilirubin (1.1 to less than 1.6 x ULN: 5%; 1.6 to less than 2.6 x ULN: 2%), AST (2.5 to less than 5 x ULN: 4%; at least 5 x ULN: less than 1%), and ALT (2.5 to less than 5 x ULN: 3%; at least 5 x ULN: 1%) have been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).

Renal

Common (1% to 10%): Increased creatinine

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Common (1% to 10%): Increased creatinine

Increased creatinine (greater than 1.3 to 1.8 x ULN or increased greater than 0.3 mg/dL above baseline: 3%; greater than 1.8 x ULN or increased at least 1.5 x above baseline: 2%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).

Musculoskeletal

Increased creatine kinase (6 to less than 10 x ULN: 2%; at least 10 x ULN: 3%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).

Common (1% to 10%): Increased creatine kinase

Doravirine/lamivudine/tenofovir DF:

-Common (1% to 10%): Increased creatine kinase

Dermatologic

Common (1% to 10%): Rash (included rash, erythematous rash, generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash)

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Common (1% to 10%): Rash

Psychiatric

Uncommon (0.1% to 1%): Abnormal dreams, insomnia

Doravirine (the active ingredient contained in Pifeltro) lamivudine/tenofovir DF:

-Very common (10% or more): Neuropsychiatric side effects (24%), sleep disorders and disturbances (included abnormal dreams, hyposomnia, initial insomnia, insomnia, nightmare, sleep disorder, somnambulism; 12%)

-Common (1% to 10%): Abnormal dreams, insomnia, depression, suicide/self-injury

Immunologic

Combination antiretroviral therapy:

-Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Pifeltro