Applies to doravirine: oral tablet.
Serious side effects of Doravirine
Along with its needed effects, doravirine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Other side effects of Doravirine
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 in patients with no antiretroviral treatment history 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/emtricitabine/tenofovir DF). Most (77%) side effects associated with this drug were of mild severity (grade 1).
The safety of doravirine/emtricitabine/tenofovir DF in virologically-suppressed patients was assessed in a trial where virologically-suppressed patients were switched from a baseline regimen to doravirine/emtricitabine/tenofovir DF; overall, the safety profile in virologically-suppressed patients was similar to the safety profile in patients with no antiretroviral treatment history.
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.[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Hypertension[Ref]
Dermatologic
Common (1% to 10%): Rash (included rash, erythematous rash, generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, urticarial)
Uncommon (0.1% to 1%): Pruritus
Rare (0.01% to 0.1%): Pustular rash, allergic dermatitis, rosacea
Doravirine/lamivudine/tenofovir DF:
-Common (1% to 10%): Rash[Ref]
Gastrointestinal
Increased lipase (1.5 to less than 3 times the upper limit of normal [1.5 to less than 3 x ULN]: 7%; at least 3 x ULN: 3%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).[Ref]
Common (1% to 10%): Nausea, diarrhea, flatulence, abdominal pain (included abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, epigastric discomfort), vomiting, increased lipase
Uncommon (0.1% to 1%): Constipation, abdominal discomfort (included abdominal discomfort, epigastric discomfort), abdominal distension, dyspepsia, soft feces (included soft feces, abnormal feces), gastrointestinal motility disorder (included gastrointestinal motility disorder, frequent bowel movements), increased amylase
Rare (0.01% to 0.1%): Rectal tenesmus
Doravirine/lamivudine/tenofovir DF:
-Common (1% to 10%): Nausea, diarrhea, increased lipase, abdominal pain[Ref]
Genitourinary
Rare (0.01% to 0.1%): Urinary calculus[Ref]
Hematologic
Uncommon (0.1% to 1%): Decreased hemoglobin[Ref]
Hepatic
Increased total bilirubin (1.1 to less than 1.6 x ULN: 6%; 1.6 to less than 2.6 x ULN: 2%; at least 2.6 x ULN: less than 1%), AST (2.5 to less than 5 x ULN: 5%; at least 5 x ULN: 2%), and ALT (2.5 to less than 5 x ULN: 4%; at least 5 x ULN: 2%) have been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).
In virologically-suppressed patients, 22% and 16% of patients in the immediate switch group had ALT and AST elevations greater than 1.25 x ULN, respectively, through 48 weeks on doravirine/emtricitabine/tenofovir DF; 1% of patients had ALT or AST elevations greater than 5 x ULN through 48 weeks. No apparent patterns were observed regarding time to onset of these elevations relative to switch. In general, the ALT and AST elevations were asymptomatic and not associated with elevated bilirubin.[Ref]
Common (1% to 10%): Increased total bilirubin, increased AST, increased ALT (included increased ALT, hepatocellular injury)
Doravirine/lamivudine/tenofovir DF:
-Very common (10% or more): Increased ALT, increased AST
-Common (1% to 10%): Increased total bilirubin[Ref]
Immunologic
Combination antiretroviral therapy:
-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)[Ref]
Metabolic
Uncommon (0.1% to 1%): Hypophosphatemia
Rare (0.01% to 0.1%): Hypomagnesemia, thirst[Ref]
Musculoskeletal
Increased creatine kinase (6 to less than 10 x ULN: 3%; at least 10 x ULN: 5%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).[Ref]
Common (1% to 10%): Increased creatine kinase
Uncommon (0.1% to 1%): Myalgia, arthralgia
Rare (0.01% to 0.1%): Musculoskeletal pain
Doravirine/lamivudine/tenofovir DF:
-Common (1% to 10%): Increased creatine kinase[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness, somnolence
Uncommon (0.1% to 1%): Disturbance in attention, memory impairment, paresthesia, hypertonia, poor quality sleep
Doravirine/lamivudine/tenofovir DF:
-Common (1% to 10%): Dizziness, headache, altered sensorium (included altered state of consciousness, lethargy, somnolence, syncope), somnolence[Ref]
Other
Increased alkaline phosphatase (2.5 to less than 5 x ULN: less than 1%), fasted LDL cholesterol (at least 190 mg/dL: less than 1%), and fasted triglycerides (greater than 500 mg/dL: 1%) have been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).
Fasting lipids changed from baseline to week 48 in patients with no antiretroviral treatment history; changes included increased HDL cholesterol and reduced LDL cholesterol, non-HDL cholesterol, total cholesterol, and triglycerides. Changes from baseline to week 96 were similar to changes seen at week 48.
Fasting lipids changed from baseline to week 24 in virologically-suppressed patients who switched to doravirine/emtricitabine/tenofovir DF; changes included decreased LDL cholesterol, non-HDL cholesterol, total cholesterol, triglycerides, and HDL cholesterol.[Ref]
Common (1% to 10%): Fatigue (included fatigue, asthenia, malaise), increased fasted triglycerides
Uncommon (0.1% to 1%): Asthenia, malaise
Rare (0.01% to 0.1%): Chest pain, chills, pain
Frequency not reported: Increased alkaline phosphatase, increased fasted low-density lipoprotein (LDL) cholesterol, 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, increased fasted cholesterol, increased fasted triglycerides
-Frequency not reported: Increased alkaline phosphatase, increased fasted LDL cholesterol, fasting lipids changed from baseline[Ref]
Psychiatric
Common (1% to 10%): Abnormal dreams, insomnia (included insomnia, initial insomnia, sleep disorder)
Uncommon (0.1% to 1%): Nightmare, depression (included depression, depressed mood, major depression, persistent depressive disorder), anxiety (included anxiety, generalized anxiety disorder), irritability, confusional state, suicidal ideation
Rare (0.01% to 0.1%): Aggression, hallucination, adjustment disorder, altered mood, somnambulism
Doravirine/lamivudine/tenofovir DF:
-Very common (10% or more): Neuropsychiatric side effects (up to 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[Ref]
The prevalence of neuropsychiatric side effects through week 4, at week 48, and at week 96 was 17%, 12%, and 13%, respectively, with doravirine/lamivudine/tenofovir DF.[Ref]
Renal
Increased creatinine (greater than 1.3 to 1.8 x ULN or increased greater than 0.3 mg/dL above baseline: 4%; greater than 1.8 x ULN or increased at least 1.5 x above baseline: 4%) has been reported with this drug (plus emtricitabine-tenofovir DF or abacavir-lamivudine).[Ref]
Common (1% to 10%): Increased creatinine
Rare (0.01% to 0.1%): Acute kidney injury, renal disorder, nephrolithiasis
Doravirine/lamivudine/tenofovir DF:
-Common (1% to 10%): Increased creatinine[Ref]
Respiratory
Rare (0.01% to 0.1%): Dyspnea, tonsillar hypertrophy[Ref]
