Note: This document contains side effect information about tipranavir. Some of the dosage forms listed on this page may not apply to the brand name Aptivus.
Common side effects of Aptivus include: hypercholesterolemia and hypertriglyceridemia. See below for a comprehensive list of adverse effects.
Applies to tipranavir: oral capsule liquid filled, oral solution
Oral route (Capsule; Solution)
Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. Fatal and nonfatal intracranial hemorrhage have also been reported.
Along with its needed effects, tipranavir (the active ingredient contained in Aptivus) 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 tipranavir:
Some side effects of tipranavir 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:
Applies to tipranavir: oral capsule, oral solution
The most frequent side effects reported in clinical trials with this drug (plus ritonavir) were diarrhea/loose stools, nausea, fatigue, headache, vomiting, pyrexia, abdominal pain, and hyperlipidemia. Therapy was discontinued due to side effects in 13.3% of patients using tipranavir (the active ingredient contained in Aptivus) ritonavir and 10.8% of patients using the comparator.
The manufacturer product information for ritonavir should be consulted.
Very common (10% or more): Elevated triglycerides (up to 35.9%), elevated cholesterol (up to 15.6%)
Common (1% to 10%): Hypertriglyceridemia, hyperlipidemia, dehydration, decreased appetite
Uncommon (0.1% to 1%): Anorexia, diabetes mellitus, hyperamylasemia, hypercholesterolemia, hyperglycemia
Frequency not reported: Mitochondrial toxicity, porphyria cutanea tarda
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels
Protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis
Elevated triglycerides (grade 2 [400 to 750 mg/dL]: 35.9%; grade 3 [greater than 750 to 1200 mg/dL]: 16.9%; grade 4 [greater than 1200 mg/dL]: 8%) and cholesterol (grade 2 [greater than 300 to 400 mg/dL]: 15.6%; grade 3 [greater than 400 to 500 mg/dL]: 3.3%; grade 4 [greater than 500 mg/dL]: 0.9%) have been reported at 48 weeks in controlled trials.
Grade 2 to 4 ALT and/or AST elevations (greater than 2.5 times the upper limit of normal [2.5 x ULN]: 26%), ALT elevations (grade 2 [greater than 2.5 to 5 x ULN]: 14.9%; grade 3 [greater than 5 to 10 x ULN]: 5.6%; grade 4 [greater than 10 x ULN]: 4.1%), and AST elevations (grade 2: 9.9%; grade 3: 4.5%; grade 4: 1.6%) have been reported at 48 weeks in controlled trials. In controlled clinical trials continued up to 96 weeks, 32.1% of patients developed grade 2 to 4 ALT and/or AST elevations.
Grade 3 and 4 hepatic transaminase elevations were reported in 10.3% of therapy-experienced patients in 2 large studies and in 20.3% of therapy-naive patients in 1 study; the studies were through 48 weeks. Elevated ALT or AST at baseline and hepatitis B or C coinfection were risk factors for such elevations in the 2 large studies; most patients were able to continue therapy with this drug (plus ritonavir).
Clinical hepatitis and hepatic decompensation (including some fatalities) have been reported with this drug (plus ritonavir); generally in patients with advanced HIV-1 disease taking multiple concomitant medications.
Significant liver toxicity has been reported with this drug (plus ritonavir). In at least 2 clinical trials, the frequency of transaminase elevations was significantly increased with this drug (plus ritonavir) compared to the comparator.
Very common (10% or more): Elevated ALT and/or AST (up to 32.1%), increased hepatic transaminases (up to 20.3%), elevated ALT (up to 14.9%)
Common (1% to 10%): Elevated AST, elevated GGT
Uncommon (0.1% to 1%): Increased hepatic enzymes, cytolytic hepatitis, abnormal liver function tests, hepatitis, toxic hepatitis, hepatic steatosis
Rare (less than 0.1%): Hepatic failure (including fatalities), hyperbilirubinemia
Frequency not reported: Clinical hepatitis, hepatic decompensation, liver toxicity, hepatic impairment
Very common (10% or more): Diarrhea (15%), nausea
Common (1% to 10%): Vomiting, elevated amylase, abdominal pain, upper abdominal pain, abdominal distension, dyspepsia, flatulence, elevated lipase
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, pancreatitis
Elevated amylase (grade 3 [greater than 2.5 x ULN]: 5.7%; grade 4 [greater than 5 x ULN]: 0.3%) has been reported at 48 weeks in controlled trials.
Common (1% to 10%): Rash (including with joint pain/stiffness, throat tightness, generalized pruritus, myalgia, fever, erythema, desquamation, mucosal erosions), pruritus
Uncommon (0.1% to 1%): Exanthem, lipoatrophy, lipohypertrophy, acquired lipodystrophy
Rare (less than 0.1%): Facial wasting
Frequency not reported: Urticarial rash, maculopapular rash, photosensitivity (possible), rash (with joint pain/stiffness, throat tightness, generalized pruritus
Rash (including urticarial rash, maculopapular rash, and possible photosensitivity) has been reported in 8% of males and 10% of females using this drug (plus ritonavir) through 48 weeks of therapy. The time to onset and duration of rash averaged 53 and 22 days, respectively. Some cases of rash occurred in conjunction with joint pain or stiffness, throat tightness, and generalized pruritus. Cases of rash (some severe) with myalgia, fever, erythema, desquamation, and mucosal erosions have been reported. Rash has been reported more often in pediatric patients than in adults.
Common (1% to 10%): Decreased WBC counts, anemia, neutropenia
Uncommon (0.1% to 1%): Thrombocytopenia
Frequency not reported: Bleeding event (not otherwise specified)
Protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs
Decreased WBC count (grade 3 [less than 2000/mcL]: 5.4%; grade 4 [less than 1000/mcL]: 0.3%) has been reported at 48 weeks in controlled trials.
Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A and B has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Muscle spasms
Frequency not reported: Muscle cramps, elevated creatine phosphokinase (CPK)
Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis
Protease inhibitor therapy:
-Rare (less than 0.1%): Rhabdomyolysis
-Frequency not reported: Increased CPK, myalgia, myositis
Cases of fatal and nonfatal intracranial hemorrhage have been reported with this drug (plus ritonavir). Many of the patients had other medical conditions or were using concomitant medications that may have contributed to or caused these events. No pattern of abnormal hematologic or coagulation parameters was observed in patients in general or preceding development of intracranial hemorrhage.
An increased risk of intracranial hemorrhage was previously observed in patients with advanced HIV disease/AIDS, such as those treated in clinical trials with this drug.
Common (1% to 10%): Headache, peripheral neuropathy
Uncommon (0.1% to 1%): Dizziness, somnolence, intracranial hemorrhage
Frequency not reported: Cerebrovascular accident
Common (1% to 10%): Pyrexia, fatigue, decreased weight
Uncommon (0.1% to 1%): Influenza-like illness, malaise
Frequency not reported: Asthenia, reactivation of herpes simplex, reactivation of varicella zoster, sepsis
-Frequency not reported: Increased weight
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Sleep disorder
Frequency not reported: Depression
Common (1% to 10%): Dyspnea
Frequency not reported: Bronchitis, cough, nasopharyngitis, upper respiratory tract infection, pneumonia, epistaxis
Uncommon (0.1% to 1%): Hypersensitivity reactions
Uncommon (0.1% to 1%): Renal failure
Frequency not reported: Renal insufficiency
Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Aptivus