Pronunciation:

in-DIN-a-vir

Brand Names:

• Crixivan

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Protease Inhibitor

Uses of This Medicine:

Indinavir is used alone or in combination with other anti-HIV medicines to treat infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Indinavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Indinavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of indinavir in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indinavir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving indinavir.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Alprazolam
• Amiodarone
• Astemizole
• Atazanavir
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Finerenone
• Flibanserin
• Gepirone
• Isavuconazonium Sulfate
• Ivabradine
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mavacamten
• Methylergonovine
• Midazolam
• Naloxegol
• Nimodipine
• Pacritinib
• Pimozide
• Ranolazine
• Sildenafil
• Silodosin
• Simvastatin
• Terfenadine
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Alfentanil
• Apalutamide
• Aprepitant
• Aripiprazole
• Artemether
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Bedaquiline
• Belzutifan
• Benzhydrocodone
• Boceprevir
• Bosutinib
• Brentuximab Vedotin
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Cabazitaxel
• Cabotegravir
• Cabozantinib
• Calcifediol
• Carbamazepine
• Cariprazine
• Ceritinib
• Cerivastatin
• Cilostazol
• Clozapine
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclophosphamide
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darunavir
• Dasatinib
• Deflazacort
• Delamanid
• Dexamethasone
• Dihydrocodeine
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Duvelisib
• Elacestrant
• Elagolix
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Erlotinib
• Eszopiclone
• Ethinyl Estradiol
• Etravirine
• Everolimus
• Fedratinib
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fluconazole
• Fluticasone
• Fosaprepitant
• Fosnetupitant
• Garlic
• Gilteritinib
• Glasdegib
• Hydrocodone
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Ifosfamide
• Iloperidone
• Infigratinib
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Levomilnacipran
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lurbinectedin
• Macitentan
• Manidipine
• Meperidine
• Methadone
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mobocertinib
• Neratinib
• Netupitant
• Nilotinib
• Norethindrone
• Norgestimate
• Olaparib
• Olutasidenib
• Omaveloxolone
• Omeprazole
• Orlistat
• Osilodrostat
• Oxycodone
• Palbociclib
• Palovarotene
• Panobinostat
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenobarbital
• Pimavanserin
• Piperaquine
• Pirtobrutinib
• Ponatinib
• Pralsetinib
• Primidone
• Quetiapine
• Quizartinib
• Reboxetine
• Regorafenib
• Retapamulin
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rimegepant
• Ritlecitinib
• Rivaroxaban
• Romidepsin
• Rosuvastatin
• Ruxolitinib
• Salmeterol
• Saquinavir
• Selpercatinib
• Selumetinib
• Simeprevir
• Sirolimus Protein-Bound
• Sonidegib
• Sparsentan
• St John's Wort
• Sufentanil
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Temsirolimus
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tipranavir
• Tocilizumab
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Trofinetide
• Upadacitinib
• Valbenazine
• Vardenafil
• Vemurafenib
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Zanubrutinib
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Amprenavir
• Aripiprazole Lauroxil
• Ascorbic Acid
• Clarithromycin
• Clevidipine
• Cobicistat
• Cyclosporine
• Dalfopristin
• Delavirdine
• Didanosine
• Diltiazem
• Efavirenz
• Felodipine
• Isradipine
• Itraconazole
• Levodopa
• Nevirapine
• Nicardipine
• Nifedipine
• Nisoldipine
• Quinupristin
• Ritonavir
• Verapamil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Hemolytic anemia (a blood disorder) or
• Hemophilia (a bleeding disorder) or
• Hepatitis or
• Hyperbilirubinemia (high bilirubin in the blood) or
• Hyperglycemia (high blood sugar) or
• Nephrolithiasis (kidney stones)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

Indinavir is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment. Your dose of indinavir may depend on the other medicines you are using.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

This medicine should be taken with water on an empty stomach (1 hour before or 2 hours after a meal) or with a light meal. Indinavir may also be taken with other liquids (eg, skim milk, juice, coffee, or tea) or with a light meal (eg, dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar).

While you are taking indinavir, it is important that you drink extra fluids so that you will pass more urine. This will help prevent possible kidney stones. Follow your doctor's instructions carefully about how much fluid to drink. Usually you will need to drink at least 48 ounces (1.5 liters or 6 full glasses) of fluids every day during your treatment.

Keep taking indinavir for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.

If you miss a dose or forget to use your medicine less than 2 hours, use it as soon as you can. If your next regular dose is more than 2 hours, wait until then to use the medicine and skip the missed dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of HIV infection:
    • Adults—800 milligrams (mg) every 8 hours. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Indinavir capsules are very sensitive to moisture. Keep them in their original container and leave the drying packet in the container.

Precautions While Using This Medicine:

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

Do not take any other medicines without checking first with your doctor. To do so may increase the chance of side effects from indinavir or other medicines.

You should not use this medicine if you are also using alfuzosin (Uroxatral®), alprazolam (Xanax®), amiodarone (Cordarone®), cisapride (Propulsid®), ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergotrate®, Methergine®, Migranal®, Wigraine®), lovastatin (Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil (Revatio®), simvastatin (Zocor®), St. John's wort, or triazolam (Halcion®). Using any of them together with this medicine may increase the chance of serious side 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 or vitamin supplements.

This medicine may raise your blood sugar. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may increase your risk of having kidney stones. Check with your doctor right away if you have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

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

This medicine may cause you to have excess body fat. Tell your doctor if you 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. You might also lose fat from the legs, arms, and face.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. Also, it 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Blood in the urine

sharp back pain just below the ribs

Less common

Abdominal or stomach pain

chills

clay-colored stools

dark urine

dizziness

fever

headache

itching

loss of appetite

nausea

rash

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Rare

Confusion

dehydration

dry or itchy skin

fruity mouth odor

increased hunger

increased thirst

increased urination

pale skin

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight loss

Some side effects 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

Change in sense of taste

diarrhea

difficulty with sleeping

generalized weakness

Less common

Acid or sour stomach

acid regurgitation

belching

cough

general feeling of discomfort or illness

heartburn

increase in appetite

indigestion

sleepiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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