What is it and how is it used?

Pharmacotherapeutic Group

CRIXIVAN is a member of a class of medicinal products called protease inhibitors. It is active against the Human Immunodeficiency Virus (HIV) helping to reduce the number of HIV particles in blood.

Therapeutic Indications

CRIXIVAN should be used in combination with other antiretroviral agents for the treatment of HIV?1 infected adult and paediatric patients.

CRIXIVAN has been shown to help reduce the risk of developing illnesses associated with HIV disease. CRIXIVAN has also been shown to help lower the amount of HIV in your body (called ?viral load?) and raise your CD4 (T) cell count. CD4 cells play a role in maintaining a healthy immune system to help fight infection. CRIXIVAN may not have these effects in all patients.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take CRIXIVAN

  • if you are allergic (hypersensitive) to indinavir or any of the other ingredients of CRIXIVAN. Signs and symptoms of an allergic reaction may include: itchy skin, redness of the skin, wheals or hives, swelling of the face, lips, tongue and/or throat, or difficulty breathing.

Do not take CRIXIVAN with or without ritonavir

  • if you take products containing rifampicin, amiodarone, terfenadine, astemizole, cisapride, alprazolam, triazolam, oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety), pimozide ergot derivatives such as ergot tartramine and ergot tartramine with caffeine, St. John's wort ( Hypericum perforatum), simvastatin or lovastatin.

In addition, do not take CRIXIVAN with ritonavir

  • if you take products containing alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam, and flurazepam.
  • if you have decompensated liver disease.

When CRIXIVAN is used with ritonavir, please tell your doctor and refer to the package leaflet for ritonavir for more information.

Take special care with CRIXIVAN

You should know that CRIXIVAN is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease. You should, therefore, remain under the care of your doctor while taking CRIXIVAN.

HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with CRIXIVAN has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.

Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.

Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

Bone problems
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Tell your doctor

  • about any past or present medical problems, including liver disease due to cirrhosis;
  • if you have kidney problems (including back pain with or without blood in your urine);
  • if you have allergies;
  • if you have high cholesterol and if you are taking cholesterol?lowering medicines called ?statins?;
  • if you have diabetes;
  • if you have haemophilia;
  • if you are intolerant to lactose because each hard capsule contains 74.8 mg lactose (anhydrous).

Children

CRIXIVAN can be taken by children 4 years of age and older who are able to swallow hard capsules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

There are some medicines that should not be taken with CRIXIVAN with or without ritonavir (see Do not take CRIXIVAN) or that require dosage changes of that medicine or CRIXIVAN (e.g., itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine and efavirenz).

Consult your doctor before taking certain cholesterol?lowering medicines (e.g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e.g., fluconazole), anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine), steroids (e.g., dexamethasone), protease inhibitors (e.g., amprenavir, saquinavir, atazanavir), medicines for impotence (e.g., sildenafil), blood thinners (e.g., warfarin), calcium channel blockers (e.g., amlodipine, felodipine?class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e.g. midazolam administered by injection), antidepressants (e.g., venlafaxine), oral contraceptives (e.g. "the Pill"), medicines for asthma (e.g., theophylline) or any other medicines.

CRIXIVAN may be taken with a number of medicines that are commonly used in HIV infection (zidovudine, didanosine, lamivudine, stavudine, quinidine, cimetidine, clarithromycin, isoniazid, fluconazole, trimethoprim/sulfamethoxazole, methadone).

Some medications may interact with CRIXIVAN taken in combination with ritonavir. Please consult with your physician regarding taking medications with CRIXIVAN and ritonavir.

Taking CRIXIVAN with food and drink

CRIXIVAN should be taken without food but with water. If co-administered with ritonavir, CRIXIVAN may be administered with or without food.
If water is not preferred, CRIXIVAN can be taken with skimmed or low?fat milk, juice, coffee, or tea. If CRIXIVAN cannot be taken without food, a low?fat light meal, such as dry toast with jam or fruit conserve, juice and coffee with skimmed or low?fat milk and sugar, or a light meal such as corn flakes with skimmed or low?fat milk and sugar is acceptable.

Taking CRIXIVAN with a meal that is high in calories, fat, and protein reduces your body?s ability to absorb the medicine and in turn reduces its effectiveness.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or intend to become pregnant.
If you are pregnant, you should take CRIXIVAN only if your doctor decides it is clearly needed. It is not known whether CRIXIVAN is harmful to an unborn baby when taken by a pregnant woman. Tell your doctor if you are breast?feeding.
It is recommended that HIV-infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

Driving and using machines

There is no specific information to suggest that CRIXIVAN affects your ability to drive and use machinery. However, dizziness and blurred vision have been reported during treatment with CRIXIVAN. Do not drive or operate machines if you experience these symptoms.

Important information about some of the ingredients of CRIXIVAN

This medicinal product contains 299.2 mg of lactose in each 800-mg dose (maximum single dose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Crixivan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults is 800 mg every 8 hours. An alternative dosing schedule for adults is CRIXIVAN 400 mg with ritonavir 100 mg both administered orally twice a day.

The dose for children and adolescents will be determined by the doctor.

For all dosages, use a combination of the 100?mg, 200?mg or 400?mg hard capsules, as appropriate.

CRIXIVAN must be taken at regular intervals of 8 hours for full effectiveness and either 1 hour before or 2 hours after a meal.

CRIXIVAN should be swallowed unchewed together with water.

It is important for adults to drink at least 1.5 litres (approximately 48 fluid ounces) of liquids during each day while taking CRIXIVAN to help reduce the risk of forming kidney stones. It is also important for children and adolescents to drink enough liquids during the course of the day. The doctor will tell you the amount of liquids your child should drink.

Your doctor will tell you how long the treatment with CRIXIVAN will last.

If you take more CRIXIVAN than you should

In clinical studies, doses higher than 800 mg every 8 hours have not been shown to have any better effect.

Contact your doctor if you have taken more than the prescribed dose of CRIXIVAN. The most common signs and symptoms of overdose are: nausea, vomiting, diarrhoea, back pain and blood in the urine. There is at present little information on the treatment of overdosage.

If you forget to take CRIXIVAN

If you have missed a dose, do not take it later in the day. Simply continue to follow your usual schedule.

If you stop taking CRIXIVAN

It is important that you take CRIXIVAN exactly as your doctor prescribes. Do not stop taking it because reducing or missing doses will increase the risk of the HI?Virus becoming resistant to CRIXIVAN, in which case treatment with this medicine will become ineffective.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, CRIXIVAN can cause side effects, although not everybody gets them.The following terms are used to describe how often side effects have been reported. Very common (occurring in at least 1 in 10 patients treated)
Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)
Not known (cannot be estimated from the available data)

Blood and the lymphatic disorders:
Not known: low red blood cell count

Immune system disorders:

Not known: allergic reactions (sometimes severe, including shock)

Nervous system disorders:

Very common: dizziness; headache;
Common: inability to sleep decreased or abnormal skin sensation
Not known: numbness of the mouth

Gastrointestinal disorders:
Very common: nausea; vomiting; diarrhoea; an uncomfortable feeling in the stomach or belching after eating
Common: wind; dry mouth; acid regurgitation
Not known: inflammation of the pancreas; inflammation of the liver; liver failure

Skin and subcutaneous tissue disorders:

Very common: dry skin; rash
Common: itching
Not known: severe skin reactions; hair loss; darkening skin colour; ingrown toenails with or without infection

Musculoskeletal connective tissue and bone disorders:

Common: muscle pain

Renal and urinary disorders:

Common: pain on urination
Not known: infection of the kidneys, decreased kidney function, loss of renal function.

General disorders and administration site conditions:

Very common: weakness/fatigue; taste perversion; abdominal pain/swelling.

Ask your doctor or pharmacist for more information about side effects. Both have a more complete list of side effects.

There have been reports of inflammation of the kidneys and kidney stones. In some of these patients, this led to more severe kidney problems including kidney failure. In most cases, kidney impairment and kidney failure were reversible. Call your doctor if you develop sudden severe back pain, with or without blood in the urine, caused by kidney stones.

Your doctor will want to test your blood regularly to detect possible abnormalities such as rapid breakdown of red blood cells (anaemia), elevation of liver enzyme levels, impairment of kidney function, changes in blood sugar levels (hyperglycaemia).

In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor. Should this happen to you, seek immediate advice from your doctor.

Inform your doctor as soon as possible if you develop severe muscle pain or weakness. Severe muscle pain and weakness have occurred in patients taking protease inhibitors, including CRIXIVAN, together with cholesterol?lowering medicines called ?statins?. There have also been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues in patients not taking statins. On rare occasions these muscle disorders have been serious (rhabdomyolysis).

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipidaemia (increased fats in the blood) and resistance to insulin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use CRIXIVAN after the expiry date stated on the bottle or carton. The expiry date refers to the last day of the month.

Store CRIXIVAN in the original bottle. Keep the bottle tightly closed in order to protect from moisture. The bottles contain desiccant canisters that should remain in the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What CRIXIVAN contains

  • The active substance is indinavir sulphate. Each hard capsule contains indinavir sulphate corresponding to 200 mg of indinavir.
  • The other excipients are anhydrous lactose, magnesium stearate, gelatin and titanium dioxide (E 171). The capsules are printed with printing ink containing indigo carmine (E 132).
What CRIXIVAN look like and content of the pack

CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil induction cap containing 180, 270 or 360 capsules. Not all pack sizes may be marketed.

The capsules are semi-translucent white and coded CRIXIVANTM 200 mg in blue.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom

Manufacturer: Merck Sharp & Dohme B.V. , Waarderweg 39 , Postbus 581 , 2003 PC HaarlemThe Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 2 373 42 11 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 2 373 42 11 MSDBelgiuminfomerck.com

. 359 2 819 3740 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 361 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta A.M.Mangion Ltd. Tel 356 2540 2600 medinfomtmerck.com

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme B.V. Tel 31 0 23 5153153 msdbvnlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorge msd.no

Eesti Merck Sharp Dohme OÜ Tel. 372 613 9750 Nimi msdeestimerck.com Österreich Merck Sharp Dohme G.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr Polska MSD Polska Sp.z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 crixivanmsd.es România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com Portugal Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com

Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 299 8700 medinfoirelandmerck.com Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com

Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia Merck Sharp Dohme Italia S.p.A. Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Middle East Limited. 357 22866700 infocyprusmerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 8 626 1400 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija. Tel 371 7364 224 msdlvmerck.com. United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medinfoukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?.
Tel.: +370 5 278 02 47msd_lietuva@merck.com

This leaflet was last approved in

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