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Aptivus

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Aptivus

Aptivus Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aptivus (tipranavir) is a protease inhibitor of HIV-1 used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. Common side effects include diarrhea, nausea, drowsiness, dizziness, headache, or vomiting.

The recommended adult dose of Aptivus for adults is 500 mg (two 250 mg capsules or 5 mL oral solution) co-administered with 200 mg of ritonavir, twice daily. Aptivus may interact with blood thinners, bosentan, colchicine, disulfiram, enfuvirtide, fluticasone, insulin or oral diabetes medications, itraconazole or ketoconazole, methadone, omeprazole, rifabutin, salmeterol, vitamin E, antidepressants, heart or blood pressure medications, cholesterol-lowering medicines, drugs that weaken the immune system, medication used to prevent blood clots, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or seizure medications. Tell your doctor all medications and supplements you use. During pregnancy, Aptivus should be used only if prescribed. Because breast milk can transmit HIV; do not breastfeed.

Our Aptivus (tipranavir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aptivus in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking tipranavir and ritonavir have developed life-threatening medical problems including liver damage and bleeding in the brain. If you are taking these two medications, call your doctor at once if you have any of the following side effects:

  • unusual bleeding (such as a nosebleed or blood in your urine or stools);
  • problems with walking, breathing, speech, swallowing, or eye movement;
  • sudden severe headache, confusion, severe drowsiness;
  • sudden numbness or weakness on one side of the body; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Stop taking tipranavir and call your doctor at once if you have any of these serious side effects:

  • severe skin rash, blistering, peeling, or sunburn;
  • increased urination or extreme thirst;
  • rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • muscle weakness, tired feeling, joint or muscle pain, weakness or prickly feeling in your fingers or toes;
  • severe lower back pain, loss of bladder or bowel control; or
  • signs of a new infection, such as fever or chills, cough, skin lesions, or flu symptoms.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain;
  • mild headache or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aptivus (Tipranavir) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aptivus Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and Drug Interactions sections.

Diarrhea, nausea, drowsiness, dizziness, headache or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, increased thirst, change in the amount of urine.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Tipranavir can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop a rash. Taking estrogen (in birth control or hormone therapy) may increase your risk of developing this rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Aptivus (Tipranavir)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aptivus FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described, in greater detail, in other sections:

Due to the need for co-administration of APTIVUS with ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials In Adults

APTIVUS, co-administered with ritonavir, has been studied in a total of 6308 HIV-1 positive adults as combination therapy in clinical studies. Of these, 1299 treatment-experienced patients received the dose of 500/200 mg BID. Nine hundred nine (909) adults, including 541 in the 1182.12 and 1182.48 controlled clinical trials, have been treated for at least 48 weeks [see Clinical Studies].

In 1182.12 and 1182.48 in the APTIVUS/ritonavir arm, the most frequent adverse reactions were diarrhea, nausea, pyrexia, vomiting, fatigue, headache, and abdominal pain. The 48-Week Kaplan-Meier rates of adverse reactions leading to discontinuation were 13.3% for APTIVUS/ritonavir-treated patients and 10.8% for the comparator arm patients.

Adverse reactions reported in the controlled clinical trials 1182.12 and 1182.48, based on treatment-emergent clinical adverse reactions of moderate to severe intensity (Grades 2 -4) in at least 2% of treatment-experienced subjects in either treatment group are summarized in Table 2 below.

Table 2 : Adverse Reactions Reported in Randomized, Controlled Clinical Trials (1182.12 and 1182.48) Based on Treatment-Emergent Clinical Adverse Reactions of Moderate to Severe Intensity (Grades 2 -4) in at least 2% of Treatment-Experienced Subjects in either Treatment Groupa (48-week Analyses)

  Percentage of patients (rate per 100 patient-exposure years)
APTIVUS/ritonavir (500/200 mg BID) + OBRc (n=749; 757.4 patient-exposure years) Comparator PI/ritonavirb + OBR (n=737; 503.9 patient-exposure years)
Blood and Lymphatic Disorders
  Anemia 3.3% (3.4) 2.3% (3.4)
  Neutropenia 2.0% (2.0) 1.0% (1.4)
Gastrointestinal Disorders
  Diarrhea 15.0% (16.5) 13.4% (21.6)
  Nausea 8.5% (9.0) 6.4% (9.7)
  Vomiting 5.9% (6.0) 4.1% (6.1)
  Abdominal pain 4.4% (4.5) 3.4% (5.1)
  Abdominal pain upper 1.5% (1.5) 2.3% (3.4)
General Disorders
  Pyrexia 7.5% (7.7) 5.4% (8.2)
  Fatigue 5.7% (5.9) 5.6% (8.4)
Investigations
  Weight decreased 3.1% (3.1) 2.2% (3.2)
  ALT increased  2.0% (2.0) 0.5% (0.8)
  GGT increased 2.0% (2.0) 0.4% (0.6)
Metabolism and Nutrition Disorders
  Hypertriglyceridemia 3.9% (4.0) 2.0% (3.0)
  Hyperlipidemia 2.5% (2.6) 0.8% (1.2)
  Dehydration 2.1% (2.1) 1.1% (1.6)
Musculoskeletal and Connective Tissue Disorders
  Myalgia 2.3% (2.3) 1.8% (2.6)
Nervous System Disorders
  Headache 5.2% (5.3) 4.2% (6.3)
  Peripheral neuropathy 1.5% (1.5) 2.0% (3.0)
Psychiatric Disorders
  Insomnia 1.7% (1.7) 3.7% (5.5)
Respiratory, Thoracic and Mediastinal Disorders
  Dyspnea 2.1% (2.1) 1.0% (1.4)
Skin and Subcutaneous Tissue Disorders
  Rash 3.1% (3.1) 3.8% (5.7)
aExcludes laboratory abnormalities that were Adverse Events
bComparator PI/ritonavir: lopinavir/ritonavir 400/100 mg BID, indinavir/ritonavir 800/100 mg BID, saquinavir/ritonavir 1000/100 mg BID, amprenavir/ritonavir 600/100 mg BID
cOptimized Background Regimen

Less Common Adverse Reactions

Other adverse reactions reported in < 2% of adult patients (n=1474) treated with APTIVUS/ritonavir 500/200 mg in Phase 2 and 3 clinical trials are listed below by body system:

Blood and Lymphatic System Disorders: thrombocytopenia

Gastrointestinal Disorders: abdominal distension, dyspepsia, flatulence, gastroesophageal reflux disease, pancreatitis

General Disorders: influenza-like illness, malaise

Hepatobiliary Disorders: hepatitis, hepatic failure, hyperbilirubinemia, cytolytic hepatitis, toxic hepatitis, hepatic steatosis

Immune System Disorders: hypersensitivity

Investigations: hepatic enzymes increased, liver function test abnormal, lipase increased

Metabolism and Nutrition Disorders: anorexia, decreased appetite, diabetes mellitus, facial wasting, hyperamylasemia, hypercholesterolemia, hyperglycemia, mitochondrial toxicity

Musculoskeletal and Connective Tissue Disorders: muscle cramp

Nervous System Disorders: dizziness, intracranial hemorrhage, somnolence

Psychiatric Disorders: sleep disorder

Renal and Urinary Disorders: renal insufficiency

Skin and Subcutaneous System Disorders: exanthem, lipoatrophy, lipodystrophy acquired, lipohypertrophy, pruritus

Laboratory Abnormalities

Treatment-emergent laboratory abnormalities reported at 48 weeks in the controlled clinical trials 1182.12 and 1182.48 in adults are summarized in Table 3 below.

Table 3 : Treatment-Emergent Laboratory Abnormalities Reported in ≥ 2% of Adult Patients (48-week Analyses)

  Limit Randomized, Controlled Clinical Trials 1182.12 and 1182.48
Percentage of Patients (rate per 100 patient-exposure years)
APTIVUS/ritonavir (500/200 mgBID) + OBR
(n=738)
Comparator PI/ritonavir + OBR*
(n=724)
Hematology
  WBC count decrease
    Grade 3  < 2.0 x 103/μL 5.4% (5.6) 4.8% (7.7)
    Grade 4 < 1.0 x 103/μL 0.3% (0.3) 1.1% (1.7)
Chemistry
  Amylase
    Grade 3 > 2.5 x ULN 5.7% (5.9) 6.4% (10.4)
    Grade 4 > 5 x ULN 0.3% (0.3) 0.7% (1.1)
  ALT
    Grade 2 > 2.5-5 x ULN 14.9% (16.5) 7.5% (12.4)
    Grade 3 > 5-10 x ULN 5.6% (5.7) 1.7% (2.6)
    Grade 4 > 10 x ULN 4.1% (4.1) 0.4% (0.7)
  AST
    Grade 2 > 2.5-5 x ULN 9.9% (10.5) 8.0% (13.3)
    Grade 3 > 5-10 x ULN 4.5% (4.6) 1.4% (2.2)
    Grade 4 > 10 x ULN 1.6% (1.6) 0.4% (0.6)
  ALT and/or AST
    Grade 2-4 > 2.5 x ULN 26.0% (31.5) 13.7% (23.8)
  Cholesterol
    Grade 2 > 300 - 400 mg/dL 15.6% (17.7) 6.4% (10.5)
    Grade 3 > 400 - 500 mg/dL 3.3% (3.3) 0.3% (0.4)
    Grade 4 > 500 mg/dL 0.9% (1.0) 0.1% (0.2)
  Triglycerides
    Grade 2 400 - 750 mg/dL 35.9% (49.9) 26.8% (51.0)
    Grade 3 > 750 - 1200 mg/dL 16.9% (19.4) 8.7% (14.6)
    Grade 4 > 1200 mg/dL 8.0% (8.4) 4.3% (7.0)
*Comparator PI/ritonavir: lopinavir/ritonavir 400/100 mg BID, indinavir/ritonavir 800/100 mg BID, saquinavir/ritonavir 1000/100 mg BID, amprenavir/ritonavir 600/100 mg BID

In controlled clinical trials 1182.12 and 1182.48 extending up to 96 weeks, the proportion of patients who developed Grade 2-4 ALT and/or AST elevations increased from 26% at week 48 to 32.1% at week 96 with APTIVUS/ritonavir. The risk of developing transaminase elevations is greater during the first year of therapy.

Clinical Trials In Pediatric Patients

APTIVUS, co-administered with ritonavir, has been studied in a total of 135 HIV-1 infected pediatric patients age 2 through 18 years as combination therapy. This study enrolled HIV-1 infected, treatment-experienced pediatric patients (with the exception of 3 treatment-na´ve patients), with baseline HIV-1 RNA of at least 1500 copies/mL. One hundred and ten (110) patients were enrolled in a randomized, open-label 48-week clinical trial (Study 1182.14) and 25 patients were enrolled in other clinical studies including Expanded Access and Emergency Use Programs.

The adverse reactions profile seen in Study 1182.14 was similar to adults. Pyrexia (6.4%), vomiting (5.5%), cough (5.5%), rash (5.5%), nausea (4.5%), and diarrhea (3.6%) were the most frequently reported adverse reactions (Grade 2-4, all causes) in pediatric patients. Rash was reported more frequently in pediatric patients than in adults.

The most common Grade 3-4 laboratory abnormalities were increases in CPK (11%), ALT (6.5%), and amylase (7.5%).

Due to previous reports of both fatal and non-fatal intracranial hemorrhage (ICH), an analysis of bleeding events was performed. At 48 weeks of treatment, the frequency of pediatric patients with any bleeding adverse reactions was 7.5%. No drug related serious bleeding adverse reaction was reported. The most frequent bleeding adverse reaction was epistaxis (3.7%). No other bleeding adverse reaction was reported in frequency of > 1%. Additional trial follow-up through 100 weeks showed a cumulative 12% frequency of any bleeding adverse reaction.

Read the entire FDA prescribing information for Aptivus (Tipranavir) »

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Aptivus - User Reviews

Aptivus User Reviews

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Here is a collection of user reviews for the medication Aptivus sorted by most helpful. Patient Discussions FAQs

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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