Aptivus Side Effects

Generic name: tipranavir

Medically reviewed by Drugs.com. Last updated on Jun 5, 2024.

Note: This document provides detailed information about Aptivus Side Effects associated with tipranavir. Some dosage forms listed on this page may not apply specifically to the brand name Aptivus.

Applies to tipranavir: oral capsule liquid filled.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

You should not use tipranavir (the active ingredient contained in Aptivus) together with alfuzosin (Uroxatral®), amiodarone (Cordarone®, Pacenone®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Methergine®, Migranal®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), oral lurasidone (Latuda®), midazolam (Versed®) pimozide (Orap®), propafenone (Rythmol®), quinidine (Cardioquin®, Quinaglute Dura®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®). Using these medicines together with tipranavir may increase your chance of having serious medical problems.

This medicine may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, a diaphragm, or contraceptive foam or jelly.

This medicine may cause intracranial hemorrhage (bleeding in the brain). Make sure your doctor knows if you or your child have a bleeding disorder, or any medical condition that increases your chance of bleeding. Call your doctor right away if you have any unusual or unexplained bleeding.

Check with your doctor right away if you or your child have pain in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, fever or chills, itching, joint or muscle pain, severe rash, red skin lesions, sunburn, throat tightness, or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.

Common side effects of Aptivus

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:

Serious side effects of Aptivus

Along with its needed effects, tipranavir 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:

For healthcare professionals

Applies to tipranavir: oral capsule, oral solution.

General adverse events

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.^[Ref]

Metabolic

• 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

Antiretroviral therapy:

• 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^[Ref]

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.^[Ref]

Hepatic

• 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^[Ref]

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.^[Ref]

Gastrointestinal

• 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^[Ref]

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.^[Ref]

Dermatologic

• 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^[Ref]

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.^[Ref]

Hematologic

• 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^[Ref]

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.^[Ref]

Musculoskeletal

• 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^[Ref]

Nervous system

• Common (1% to 10%): Headache, peripheral neuropathy
• Uncommon (0.1% to 1%): Dizziness, somnolence, intracranial hemorrhage
• Frequency not reported: Cerebrovascular accident^[Ref]

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.^[Ref]

Other

• 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

Antiretroviral therapy:

• Frequency not reported: Increased weight^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Sleep disorder
• Frequency not reported: Depression^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea
• Frequency not reported: Bronchitis, cough, nasopharyngitis, upper respiratory tract infection, pneumonia, epistaxis^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal failure
• Frequency not reported: Renal insufficiency^[Ref]

Immunologic

• Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)^[Ref]

See also:

Further information

Aptivus side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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