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Delstrigo

Generic Name: doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR a VIR een, la MIV ue deen, and ten OF oh vir)
Brand Names: Delstrigo
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is used to treat HIV-1 infection. Includes Delstrigo side effects, interactions and indications.
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Drug Information:
Delstrigo containes a combination of doravirine, lamivudine and tenofovir disoproxil fumarate. Doravirine, lamivudine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. Delstrigo is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Delstrigo 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 Delstrigo, and some drugs should not be used together. Learn more

Delstrigo Side Effects

Delstrigo Side Effects

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

For the Consumer

Applies to doravirine/lamivudine/tenofovir: oral tablet

Warning

Oral route (Tablet)

Warning: Posttreatment Acute Exacerbations of Hepatitis BSevere acute exacerbations of hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of doravirine / lamivudine / tenofovir disoproxil fumarate oral tablets. Closely monitor hepatic function in these patients. If appropriate, initiation of antihepatitis B therapy may be warranted..

Along with its needed effects, doravirine / lamivudine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking doravirine / lamivudine / tenofovir:

Incidence not known

  • Bloating
  • bloody urine
  • blurred vision
  • bone fractures, especially of the femur bone
  • pain
  • chills
  • cloudy urine
  • constipation
  • cough
  • dark urine
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • difficult or labored breathing
  • difficulty swallowing
  • dizziness
  • dry mouth
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort
  • hives, itching, skin rash
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle cramps, spasms, pain, or stiffness
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • sleepiness
  • stomach pain or discomfort
  • swelling of the face, fingers, lower legs
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting
  • weight gain
  • yellow eyes or skin

Some side effects of doravirine / lamivudine / tenofovir 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

  • Trouble sleeping

Less common

  • Abnormal dreams

Incidence not known

  • Accumulation of body fat
  • lack or loss of strength
  • thinning or loss of hair

For Healthcare Professionals

Applies to doravirine / lamivudine / tenofovir: oral tablet

General

The safety of doravirine 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 this combination drug. Most (65%) side effects associated with this combination drug were of mild severity (grade 1).

Unless otherwise specified, the side effects provided below were reported during the trial using this combination drug.

Psychiatric

Most patients reported neuropsychiatric side effects as mild to moderate in severity; such events were mostly reported in the first 4 weeks of therapy. Through week 4 and at week 48, neuropsychiatric side effects were reported in 17% and 12% of patients, respectively. This drug was discontinued due to neuropsychiatric side effects in 1% of patients.

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

Nervous system

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

Gastrointestinal

Increased lipase (1.5 to less than 3 times the upper limit of normal [1.5 to less than 3 x ULN]: 5%; at least 3 x ULN: 1%) has been reported.

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

Uncommon (0.1% to 1%): Abdominal pain (included abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, epigastric discomfort)

Tenofovir DF:

-Postmarketing reports: Pancreatitis, increased amylase, abdominal pain

Hepatic

Increased total bilirubin (1.1 to less than 1.6 x ULN: 4%; 1.6 to less than 2.6 x ULN: 2%; at least 2.6 x ULN: less than 1%), ALT (2.5 to less than 5 x ULN: 3%; at least 5 x ULN: less than 1%), and AST (2.5 to less than 5 x ULN: 2%; at least 5 x ULN: less than 1%) have been reported.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Severe acute exacerbations of hepatitis B (e.g., liver decompensated, liver failure) have been reported in patients coinfected with HIV-1 and hepatitis B virus after discontinuation of products containing lamivudine and/or tenofovir DF.

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

Lamivudine:

-Postmarketing reports: Hepatic steatosis, posttreatment exacerbations of hepatitis B (e.g., liver decompensated, liver failure)

Tenofovir DF:

-Frequency not reported: Posttreatment exacerbation of hepatitis B

-Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT, GGT)

Other

Increased fasted cholesterol (at least 300 mg/dL), 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.

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 fasted cholesterol, 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)

Lamivudine:

-Postmarketing reports: Weakness

Tenofovir DF:

-Postmarketing reports: Asthenia

Renal

Increased creatinine (greater than 1.3 to 1.8 x ULN or increased greater than 0.3 mg/dL above baseline: 2%; greater than 1.8 x ULN or increased at least 1.5 x above baseline: 2%) has been reported.

Tenofovir DF:

-Postmarketing reports: Acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine

Common (1% to 10%): Increased creatinine

Musculoskeletal

Increased creatine kinase (6 to less than 10 x ULN: 2%; at least 10 x ULN: 2%) has been reported.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

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

Lamivudine:

-Postmarketing reports: Muscle weakness, elevated creatine phosphokinase, rhabdomyolysis

Tenofovir DF:

-Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism

-Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Dermatologic

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

Lamivudine:

-Postmarketing reports: Urticaria, alopecia, pruritus

Tenofovir DF:

-Postmarketing reports: Rash

Hematologic

Lamivudine:

-Postmarketing reports: Anemia (including pure red cell aplasia and severe anemias progressing on therapy)

Metabolic

Lamivudine:

-Postmarketing reports: Redistribution/accumulation of body fat, hyperglycemia, lactic acidosis

Tenofovir DF:

-Frequency not reported: Higher 1,25 vitamin D levels

-Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Hypersensitivity

Lamivudine:

-Postmarketing reports: Anaphylaxis

Tenofovir DF:

-Postmarketing reports: Allergic reaction (including angioedema)

Respiratory

Tenofovir DF:

-Postmarketing reports: Dyspnea

Genitourinary

Tenofovir DF:

-Postmarketing reports: Proteinuria, polyuria

Endocrine

Tenofovir DF:

-Frequency not reported: Higher serum parathyroid hormone levels

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 Delstrigo