CYTOVENE® 500mg Injection

CYTOVENE® 500mg Injection

SKU: 4260095681607
DIN: 02162695
SIZE: 5x10ml vials
INDICATIONS: CYTOVENE® is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), iatrogenic suppression secondary to organ transplantation or those administered chemotherapy for neoplasia. It is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease.
DIRECTIONS: At the start of treatment, CYTOVENE® is usually given every 12 hours for the first few weeks, and then once a day either 5 or 7 times a week after that, or as directed by your doctor.

Product Description

INDICATIONS AND CLINICAL USE

CYTOVENE® (ganciclovir for injection) is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), iatrogenic suppression secondary to organ transplantation or those
administered chemotherapy for neoplasia. CYTOVENE® is also indicated for the prevention of CMV disease in transplant recipients at risk
for CMV disease.

The diagnosis of CMV retinitis is primarily an ophthalmologic one and should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis include candidiasis, toxoplasmosis, histoplasmosis, retinal scars, and cotton wool spots, any of which
may produce a retinal appearance similar to CMV. For this reason it is essential that the diagnosis of CMV be established by an ophthalmologist familiar with the retinal presentation of these conditions. The diagnosis of CMV retinitis may be aided by culture of CMV from urine, blood, throat, or other sites, but a negative CMV culture does not rule out CMV retinitis.

CONTRAINDICATIONS

CYTOVENE® (ganciclovir for injection) is contraindicated in patients who are hypersensitive to ganciclovir, valganciclovir or to any of the excipients.
Due to the similarity of the chemical structure of CYTOVENE® and that of acyclovir and its prodrug valacyclovir, a cross-hypersensitivity reaction between these drugs is possible.

WARNINGS

The clinical toxicity of CYTOVENE® (ganciclovir for injection) includes severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure, and aplastic anemia.

  • In animal and in vitro studies, ganciclovir was mutagenic, teratogenic, carcinogenic and caused aspermia; therefore it should be considered a potential teratogen and carcinogen in humans.
  • CYTOVENE® is indicated for use only in immunocompromised patients, where the potential benefit outweighs the risks stated herein.
  • The safety and efficacy of CYTOVENE® have not been evaluated for congenital or neonatal CMV disease, nor for treatment of CMV infection in nonimmunocompromised individuals

Please refer to the product monograph for a complete list of warnings and precautions

ADVERSE REACTIONS

Valganciclovir is a pro-drug of ganciclovir, and adverse reactions associated with valganciclovir can be expected to occur with ganciclovir. Therefore, adverse drug reactions reported with IV or oral ganciclovir (not available) or with valganciclovir are included in the table of adverse
reactions (see Table 1 in the product monograph).
In patients treated with ganciclovir/valganciclovir the most serious and frequent adverse drug reactions are hematological reactions and include neutropenia, anemia and thrombocytopenia.

Please refer to the product monograph for a complete list of adverse reactions

ABOUT THE DISEASE

Cytomegalovirus (CMV) retinitis

Cytomegalovirus (CMV) retinitis is a viral infection of the retina of the eye resulting in inflammation.

Causes:

CMV retinitis is caused by a member of a group of herpes-type viruses. Infection with CMV is very common. Most people are exposed to CMV in their lifetime, but typically only those with weakened immune systems become ill from CMV infection.

Serious CMV infections can occur in people who have weakened immune systems as a result of:

  • HIV/AIDS
  • Bone marrow transplant
  • Chemotherapy
  • Drugs that suppress the immune system
  • Organ transplant

Diagnosis:

CMV retinitis is diagnosed through an ophthalmologic exam. Dilation of the pupils and ophthalmoscopy will show signs of CMV retinitis.

CMV infection can be diagnosed with blood or urine tests that look for substances specific to the infection. A tissue biopsy can detect the viral infection and presence of CMV virus particles, but this is rarely done.

CLINICAL TRIALS

Please check back later

RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

 

PRESCRIBING INFORMATION

Click here to download Prescribing Information

 

 

FREQUENTLY ASKED QUESTIONS

How does this medication work? What will it do for me?

CYTOVENE® belongs to a group of medications known as antivirals. It is used to treat and prevent a viral eye infection called cytomegalovirus (CMV) retinitis. This infection usually occurs for people with weakened immune systems, such as people who have had transplants or chemotherapy, and people who have AIDS. It works by preventing the virus (CMV) that causes the infection from reproducing, which helps to prevent CMV from spreading to healthy cells as quickly as it would without treatment.

CYTOVENE® is also used for the prevention of cytomegalovirus disease in people receiving a solid organ transplant who are at risk of developing the disease.

This medication should only be used by people with a weakened immune system

What form(s) does this medication come in?

CYTOVENE® is a white to off-white powder in a vial. Each vial contains the equivalent of 500 mg of an active ingredient called ganciclovir. The powder is made up by dissolving it into a liquid for injection.

How should I use this medication?

The dose of CYTOVENE® is based on body weight. CYTOVENE® is given as an intravenous (IV) infusion (injected slowly into the vein over a period of one hour). It is done in a hospital or clinic setting under the supervision of a health care professional. The dose will be determined by your doctor according to individual needs.

For treatment of CMV retinitis, the recommended starting dose of CYTOVENE® is 5 mg per kilogram of body weight, given every 12 hours for 14 to 21 days.

For prevention of CMV disease in transplant recipients, the recommended starting dose of CYTOVENE® is 5 mg per kilogram of body weight, given every 12 hours for 7 to 14 days. After this time, CYTOVENE® may be given once daily.

For Maintenance Treatment of CMV Retinitis, the dose of 5mg/kg/day may be administered once per day for 7 days or 6mg/kg/day for 5 days.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive CYTOVENE®, contact your doctor as soon as possible to reschedule your appointment

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to ganciclovir or any ingredients of this medication
  • are allergic to valganciclovir, acyclovir, or valacyclovir

What side effects are possible with this medication?

Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, shaking (tremors), or pain/redness/irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), signs of kidney problems (such as a change in the amount of urine), seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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

What other drugs could interact with this medication?

There may be an interaction between CYTOVENE® and any of the following:

  • abacavir
  • adefovir
  • didanosine
  • emtricitabine
  • entecavir
  • imipenem
  • lamivudine
  • mycophenolate
  • probenecid
  • tenofovir
  • trimethoprim

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescriptions, over-the-counter (non-prescription), and herbal medications you are taking. Also, tell them about any supplements you take. Since caffeine, alcohol, nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

What happens if I miss a dose?

If you miss a dose of CYTOVENE®, take it as soon as possible. However, if it is time for your next dose, do not double the dose, just carry on with your regular schedule.

How should CYTOVENE® be stored?

Store at room temperature (15-30°C), avoid excessive heat above 40°C (104°F).

Are there any precautions or warnings I should be aware of?

Serious blood problems can occur such as low numbers of white blood cells, red blood cells or
platelets.

Tumours have been found in laboratory animals receiving this drug, although at this time there is no
similar information from human studies. The drug also has damaging effects on the reproductive system. When used in men, it may decrease the number of sperm in the semen and this may be complete and irreversible. In women, not only may there be suppression of fertility, but pregnancy during
treatment is likely to lead to the birth of a malformed child.

BEFORE you use CYTOVENE® talk to your doctor or pharmacist if:

  • You have, or have had, low numbers of either white blood cells, red blood cells or platelets in your blood.
  • You are taking acyclovir, valganciclovir, or valacyclovir.
  • You have kidney problems.
  • You are receiving hemodialysis.
  • You are taking ANY other medicines (prescription or nonprescription) including herbal or natural products.
  • You or your partner are pregnant, plan on becoming pregnant, or are breast-feeding a child, as CYTOVENE® may cause birth defects in humans and should not be used during pregnancy. If there is any chance that you or your partner could become pregnant, it is very important for you to use effective contraception during and after treatment with CYTOVENE®. For women this means using barrier protection (condoms) and one additional form of contraception (birth control pills, intrauterine device) during and for at least 30 days after treatment with CYTOVENE®. For men this means using barrier protection (condoms) during and for at least 90 days following treatment with CYTOVENE®, unless it is certain that the female partner is not at risk of becoming pregnant.  Women who are HIV positive should not breast feed because HIV infection can be passed to the baby via the breast milk