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Crixivan

Last reviewed on RxList: 4/4/2016
Crixivan Side Effects Center

Last reviewed on RxList 1/10/2016

Crixivan (indinavir sulfate) is a type of antiviral medication called a protease inhibitor used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Crixivan is not a cure for HIV or AIDS. Common side effects of Crixivan include stomach pain, nausea, vomiting, heartburn, loss of appetite, headache, numbness or tingling (especially around your mouth), mood changes, or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

The recommended dosage of Crixivan is 800 mg (usually two 400-mg capsules) orally every 8 hours. Crixivan may interact with injectable midazolam, fluticasone, St. John's wort, antibiotics, antidepressants, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, insulin or oral diabetes medications, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or seizure medications. Many other medicines can interact with Crixivan. Tell your doctor all medications you use. During pregnancy, Crixivan should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Crixivan (indinavir sulfate) 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.

QUESTION

What is HIV? See Answer
Crixivan Consumer Information

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

Call your doctor at once if you have:

  • painful or difficult urination;
  • blood cell disorders--pale or yellowed skin, fever, dark colored urine, confusion or weakness;
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
  • symptoms of a kidney stone--pain in your side or lower back, painful or difficult urination, blood in your urine;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • (if you also use a "statin" cholesterol medicine)--unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Indinavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with indinavir. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • indigestion, heartburn;
  • changes in appetite;
  • headache, dizziness, feeling weak or tired;
  • back pain;
  • rash, itching, dry skin;
  • altered sense of taste;
  • cold symptoms such as stuffy nose, sneezing, sore throat; 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 Crixivan (Indinavir Sulfate)

SLIDESHOW

A Timeline of the HIV/AIDS Pandemic See Slideshow
Crixivan Professional Information

SIDE EFFECTS

Clinical Trials In Adults

Nephrolithiasis/urolithiasis, including flank pain with or without hematuria (including microscopic hematuria), has been reported in approximately 12.4% (301/2429; range across individual trials: 4.7% to 34.4%) of patients receiving CRIXIVAN at the recommended dose in clinical trials with a median follow-up of 47 weeks (range: 1 day to 242 weeks; 2238 patient-years follow-up). The cumulative frequency of nephrolithiasis events increases with duration of exposure to CRIXIVAN; however, the risk over time remains relatively constant. Of the patients treated with CRIXIVAN who developed nephrolithiasis/urolithiasis in clinical trials during the double-blind phase, 2.8% (7/246) were reported to develop hydronephrosis and 4.5% (11/246) underwent stent placement. Following the acute episode, 4.9% (12/246) of patients discontinued therapy. (See WARNINGS and DOSAGE AND ADMINISTRATION, Nephrolithiasis/Urolithiasis.)

Asymptomatic hyperbilirubinemia (total bilirubin ≥ 2.5 mg/dL), reported predominantly as elevated indirect bilirubin, has occurred in approximately 14% of patients treated with CRIXIVAN. In < 1% this was associated with elevations in ALT or AST.

Hyperbilirubinemia and nephrolithiasis/urolithiasis occurred more frequently at doses exceeding 2.4 g/day compared to doses ≤ 2.4 g/day.

Clinical adverse experiences reported in ≥ 2% of patients treated with CRIXIVAN alone, CRIXIVAN in combination with zidovudine or zidovudine plus lamivudine, zidovudine alone, or zidovudine plus lamivudine are presented in Table 10.

Table 10: Clinical Adverse Experiences Reported in ≥ 2% of Patients

Adverse Experience Study 028 Considered Drug-Related and of Moderate or Severe Intensity Study ACTG 320 of Unknown Drug Relationship and of Severe or Life-threatening Intensity
CRIXIVAN Percent
(n=332)
CRIXIVAN plus Zidovudine Percent
(n=332)
Zidovudine Percent
(n=332)
CRIXIVAN plus Zidovudine plus Lamivudine Percent
(n=571)
Zidovudine plus Lamivudine Percent
(n=575)
Body as a Whole
  Abdominal pain 16.6 16.0 12.0 1.9 0.7
  Asthenia/ fatigue 2.1 4.2 3.6 2.4 4.5
  Fever 1.5 1.5 2.1 3.8 3.0
  Malaise 2.1 2.7 1.8 0 0
Digestive System
  Nausea 11.7 31.9 19.6 2.8 1.4
  Diarrhea 3.3 3.0 2.4 0.9 1.2
  Vomiting 8.4 17.8 9.0 1.4 1.4
  Acid regurgitation 2.7 5.4 1.8 0.4 0
  Anorexia 2.7 5.4 3.0 0.5 0.2
  Appetite increase 2.1 1.5 1.2 0 0
  Dyspepsia 1.5 2.7 0.9 0 0
  Jaundice 1.5 2.1 0.3 0 0
Hemic and Lymphatic System
  Anemia 0.6 1.2 2.1 2.4 3.5
Musculoskeletal System
  Back pain 8.4 4.5 1.5 0.9 0.7
Nervous System/ Psychiatric
  Headache 5.4 9.6 6.0 2.4 2.8
  Dizziness 3.0 3.9 0.9 0.5 0.7
  Somnolence 2.4 3.3 3.3 0 0
Skin and Skin Appendage
  Pruritus 4.2 2.4 1.8 0.5 0
  Rash 1.2 0.6 2.4 1.1 0.5
Respiratory System
  Cough 1.5 0.3 0.6 1.6 1.0
  Difficulty breathing/ dyspnea/ shortness of breath 0 0.6 0.3 1.8 1.0
Urogenital System
  Nephrolithiasis/ urolithiasis 8.7 7.8 2.1 2.6 0.3
  Dysuria 1.5 2.4 0.3 0.4 0.2
Special Senses
  Taste perversion 2.7 8.4 1.2 0.2 0
*Including renal colic, and flank pain with and without hematuria

In Phase I and II controlled trials, the following adverse events were reported significantly more frequently by those randomized to the arms containing CRIXIVAN than by those randomized to nucleoside analogues: rash, upper respiratory infection, dry skin, pharyngitis, taste perversion.

Selected laboratory abnormalities of severe or life-threatening intensity reported in patients treated with CRIXIVAN alone, CRIXIVAN in combination with zidovudine or zidovudine plus lamivudine, zidovudine alone, or zidovudine plus lamivudine are presented in Table 11.

Table 11: Selected Laboratory Abnormalities of Severe or Life-threatening Intensity Reported in Studies 028 and ACTG 320

  Study 028 Considered Drug-Related and of Moderate or Severe Intensity Study ACTG 320 of Unknown Drug Relationship and of Severe or Life-threatening Intensity
CRIXIVAN Percent
(n=329)
CRIXIVAN plus Zidovudine Percent
(n=320)
Zidovudine Percent
(n=330)
CRIXIVAN plus Zidovudine plus Lamivudine Percent
(n=571)
Zidovudine plus Lamivudine Percent
(n=575)
Hematology
Decreased hemoglobin < 7.0 g/dL 0.6 0.9 3.3 2.4 3.5
Decreased platelet count < 50 THS/mm³ 0.9 0.9 1.8 0.2 0.9
Decreased neutrophils < 0.75 THS/mm³ 2.4 2.2 6.7 5.1 14.6
Blood chemistry
Increased ALT > 500% ULN* 4.9 4.1 3.0 2.6 2.6
Increased AST > 500% ULN 3.7 2.8 2.7 3.3 2.8
Total serum bilirubin > 250% ULN 11.9 9.7 0.6 6.1 1.4
Increased serum amylase > 200% ULN 2.1 1.9 1.8 0.9 0.3
Increased glucose > 250 mg/dL 0.9 0.9 0.6 1.6 1.9
Increased creatinine > 300% ULN 0 0 0.6 0.2 0
*Upper limit of the normal range.

Post-Marketing Experience

Body As A Whole: redistribution/accumulation of body fat (see PRECAUTIONS, Fat Redistribution).

Cardiovascular System: cardiovascular disorders including myocardial infarction and angina pectoris; cerebrovascular disorder.

Digestive System: liver function abnormalities; hepatitis including reports of hepatic failure (see WARNINGS); pancreatitis; jaundice; abdominal distention; dyspepsia.

Hematologic: increased spontaneous bleeding in patients with hemophilia (see PRECAUTIONS); acute hemolytic anemia (see WARNINGS).

Endocrine/Metabolic: new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, hyperglycemia (see WARNINGS).

Hypersensitivity: anaphylactoid reactions; urticaria; vasculitis.

Musculoskeletal System: arthralgia, periarthritis.

Nervous System/Psychiatric: oral paresthesia; depression.

Skin and Skin Appendage: rash including erythema multiforme and Stevens-Johnson syndrome; hyperpigmentation; alopecia; ingrown toenails and/or paronychia; pruritus.

Urogenital System: nephrolithiasis/urolithiasis, in some cases resulting in renal insufficiency or acute renal failure, pyelonephritis with or without bacteremia (see WARNINGS); interstitial nephritis sometimes with indinavir crystal deposits; in some patients, the interstitial nephritis did not resolve following discontinuation of CRIXIVAN; renal insufficiency; renal failure; leukocyturia (see PRECAUTIONS), crystalluria; dysuria.

Laboratory Abnormalities

Increased serum triglycerides; increased serum cholesterol.

Read the entire FDA prescribing information for Crixivan (Indinavir Sulfate)

Related Resources for Crixivan

Read the Crixivan User Reviews »

© Crixivan Patient Information is supplied by Cerner Multum, Inc. and Crixivan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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