Patient Medication Information: uses, side effects, how to take - Crixivan (Merck Canada, 300 mg)
ABOUT THIS MEDICATION
What the medication is used for:
Your physician has prescribed CRIXIVAN® for you because you have HIV infection. CRIXIVAN® can help reduce your chances of getting illnesses associated with HIV infection. CRIXIVAN® can also help lower the amount of HIV in your blood (called “viral load”) and raise your CD4 (T) cell count. CRIXIVAN® may not have these effects in all patients.
HIV is a blood-borne disease spread by contact with blood or sexual contact with an infected individual.
What it does:
CRIXIVAN® is a member of a class of drugs called protease inhibitors. It is active against the Human Immunodeficiency Virus (HIV) helping to reduce the amount of virus within the body.
When it should not be used:
- a)
Do not take CRIXIVAN® if you experience a severe
allergic reaction to any component of the drug (see What the important nonmedicinal ingredients are).
- b)
Do not take CRIXIVAN® with amiodarone, ergot
derivatives, cisapride (no longer marketed in Canada), pimozide, midazolam and triazolam.
What the medicinal ingredient is:
Indinavir sulfate
What the important nonmedicinal ingredients are: Each capsule contains the following non-medicinal ingredients: anhydrous lactose (as a dry binder/filler) and magnesium stearate (as a lubricant); and gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide (empty capsule shell).
What dosage forms it comes in:
CRIXIVAN® is available as white semi-translucent capsules containing either 100, 200, 300 or 400 mg of indinavir as the active ingredient.
WARNINGS AND PRECAUTIONS
BEFORE you use CRIXIVAN® talk to your doctor if:
- You have past or present medical problems, including liver or kidney problems, diabetes, hemophilia, high cholesterol and if you are taking cholesterol-lowering medicines called “statins”.
- You are taking or plan to take any medication, such as non-prescription drugs or natural health products including herbs or dietary supplements. Some medicines should not be taken with CRIXIVAN® or may require a dosage adjustment (see Interactions with this medication).
You are pregnant or planning to become pregnant. It is not kown whether taking CRIXIVAN® may be harmful to an unborn baby. If you are pregnant, you should take CRIXIVAN® only if your doctor decides it is needed.
- You are breastfeeding or planning to do so. You should not breastfeed while taking CRIXIVAN®. Consult your doctor.
Other Warnings
- CRIXIVAN® is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease. Continue to see your doctor regularly and report any medical problems you have.
CRIXIVAN® does not prevent a patient infected with
HIV from passing the virus to other people. To protect others, you must continue to practice safe sex and take precautions to prevent others from coming into contact with your blood and other body fluids.
The long term effects of CRIXIVAN® are unknown.
Treatment with CRIXIVAN has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
Use in children.
CRIXIVAN® can be taken by children 3 years of age and older who are able to swallow capsules.
INTERACTIONS WITH THIS MEDICATION
Medications that may not be taken with CRIXIVAN® because it could result in serious or life-threatening events (such as problems with heart rhythm or excessive sleepiness) are amiodarone (e.g. Cordarone®), alprazolam (e.g. Xanax®), triazolam (e.g. Halcion®), astemizole∗ (e.g. Hismanal™), cisapride* (e.g. Prepulsid®), terfenadine* (e.g. Seldane®), midazolam (e.g. Versed®), pimozide (e.g. Orap®), rifampin (e.g. Rifadin®, Rifater®, Rimactane®) and ergot medications (e.g. Cafergot®, Ergomar®, Wigraine®). Consult your physician before taking CRIXIVAN® with any other medication.
If you are taking protease inhibitors including CRIXIVAN®, you should not be taking some of the cholesterol-lowering medicines called “statins” (e.g. lovastatin and simvastatin) as severe muscle pain and weakness have occurred when these drugs are taken together. Consult your physician if you have further questions.
Taking CRIXIVAN® with St. John’s wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John’s wort is not recommended as it may decrease the effect of CRIXIVAN® or other HIV-related drugs.
CRIXIVAN® may be taken with a number of medications that are commonly used by people with HIV infection. These include zidovudine (AZT™, e.g. Retrovir®), didanosine (ddI, e.g. Videx®), lamivudine (e.g. 3TC®), stavudine (d4T, e.g. Zerit™), fluconazole (e.g. Diflucan®), isoniazid, clarithromycin (e.g. Biaxin®), trimethoprim/sulfamethoxazole (e.g. Bactrim®, Roubac®, Septra®), and methadone.
Other medications may be taken with CRIXIVAN® but require dosage adjustment of that medication or of CRIXIVAN®. These include rifabutin (e.g. Mycobutin®) ketoconazole (e.g. Nizoral®), itraconazole (e.g. Sporanox®), delavirdine (e.g. Rescriptor®), and efavirenz (e.g. Sustiva®).
Tell your doctor if you are taking calcium channel blockers (drugs to treat hypertension or chest pain).
Tell your doctor if you are taking venlafaxine (e.g. Effexor®).
Tell your doctor if you are taking trazodone (e.g. Desyrel®).
Tell your doctor if you are taking sildenafil (e.g. Viagra®).
Can I drive or operate machinery while using CRIXIVAN®?
Dizziness and blurred vision have been reported during treatment with CRIXIVAN®. If you experience these you should avoid driving or operating machinery.
PROPER USE OF THIS MEDICATION
Usual dose:
CRIXIVAN® is in capsule form and must be taken orally. Take 800 mg (usually given as two 400 mg capsules) at regular 8-hour
∗ no longer marketed in Canada
intervals. CRIXIVAN® must be taken at intervals of 8 hours for full effectiveness.
The dose for children and adolescents will be determined by the physician.
It is very important to take CRIXIVAN® exactly as prescribed to help ensure full effectiveness of the product. Do not stop taking it without first telling your doctor.
CRIXIVAN® should be taken with water 1 hour before or 2 hours after a meal. If water is not preferred, CRIXIVAN® can be taken with skimmed or fat-free milk, juice, coffee, or tea; or a light meal such as dry toast and jam or fruit conserve, juice and coffee with skimmed or fat-free milk and sugar; or corn flakes, skimmed or fat-free milk and sugar. At any other time you can follow your regular diet.
Taking CRIXIVAN® with a meal that is high in calories, fat, and protein reduces your body's ability to absorb the drug and in turn reduces its effectiveness.
It is important for adults to drink at least 1.5 liters (approximately 48 ounces) of liquids during each day to ensure adequate hydration. It is also important for children and adolescents to drink enough liquids during the course of the day. The physician will tell you the amount of liquid your child should drink. This may help reduce the incidence of kidney stones (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
If you take didanosine with CRIXIVAN®, take them at least one hour apart on an empty stomach.
Missed Dose:
Take CRIXIVAN® 3 times a day at regular 8-hour intervals. However, if you miss a dose by more than 2 hours, do not take it later in the day. Simply continue to follow your usual schedule. Do not take a double dose of CRIXIVAN®.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any medicine may have unintended or undesirable effects, so-called side effects. CRIXIVAN® has been shown to be generally well tolerated. There have been reports of kidney stones and in some of these patients this led to more severe kidney problems including kidney failure. In most cases, kidney impairment and kidney failure were temporary and reversible. Call your physician if you develop sudden severe back pain, with or without blood in the urine caused by kidney stones.
Some patients treated with CRIXIVAN® have had rapid breakdown of red blood cells (also called hemolytic anemia) which in some cases was severe or resulted in death.
Some patients treated with CRIXIVAN® have had liver problems including liver failure and death. Some patients had other illnesses or were taking other drugs. It is uncertain if CRIXIVAN® caused these liver problems.
Other side effects include weakness/fatigue; low red blood cell count; heart problems including heart attack; abdominal pain/swelling; inflammation of the pancreas; inflammation of the kidneys; infection of the kidneys; decreased kidney function; diarrhea; upset stomach; nausea; dizziness; headache; dry skin; change in skin color; hair loss; ingrown toenails with or without infection; crystals in the urine; numbness of the mouth; rash; severe skin reactions; allergic reactions; and taste perversion.
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term effects of these conditions are not known at this time.
In some patients with hemophilia, increased bleeding has been reported.
There have been reports of diabetes and increased blood sugar (also called hyperglycemia) in patients treated with protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition resulting from poorly controlled blood sugar. Before starting protease inhibitors, some patients already had diabetes, others did not. Some patients required adjustments to their diabetes medication. Other patients needed new diabetes medication.
Your physician has a more complete list of side effects.
Tell your physician promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.
In addition, tell your physician if you experience any symptoms that suggest an allergic reaction after taking CRIXIVAN®.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Kidney problems including kidney stones, kidney failure and symptoms such as back pain, blood in the urine | T | ||
Hemolytic anemia, the rapid breakdown of blood cells and symptoms such as jaundice and dark urine | T | |||
| Uncommon | Severe allergic reaction/diffi-culty of breathing | T | T | |
| Increased bleeding in hemophiliacs | T | |||
New onset/worse-ning of diabetes | T | |||
| Uncommon | Hepatitis | T | ||
This is not a complete list of side effects. For any unexpected effects while taking CRIXIVAN®, contact your doctor or pharmacist.
Other considerations
Although CRIXIVAN® is not a cure for HIV infection, CRIXIVAN® can help increase the amount of time you will spend living without disease associated with HIV.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur when combination antiretroviral treatment is started.
See your physician for more details.
HOW TO STORE IT
Protect from moisture.
- Keep CRIXIVAN® capsules in the bottle they came in and at room temperature (15°C-30°C).
- Keep CRIXIVAN® capsules dry by leaving the small desiccant in the bottle. Keep the bottle closed.
Keep all medicines out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this vaccine you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
or Merck Frosst Canada Ltd. by:
Toll-free telephone: 800-567-2594
Toll-free fax: 877-428-8675
By regular mail:
Merck Frosst Canada Ltd.
P.O. Box 1005
Pointe-Claire - Dorval, QC H9R 4P8
NOTE: Before contacting Health Canada or Merck Frosst, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.merckfrosst.com or by contacting the sponsor, Merck Frosst Canada Ltd., at: 1-800-567-2594,
Last revised: February 13, 2007
CRIXIVAN® is a Registered Trademark of Merck & Co., Inc. Used under license.