Consumer Information for: TEVA-VALGANCICLOVIR
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- TEVA-VALGANCICLOVIR is a prescription medication that belongs to the family of drugs known as “antivirals”.
- TEVA-VALGANCICLOVIR is used to treat cytomegalovirus (CMV) retinitis in adults who have acquired immunodeficiency syndrome (AIDS).
- TEVA-VALGANCICLOVIR is also used to prevent cytomegalovirus (CMV) disease in adults who have received a solid organ transplant and are at risk of developing CMV disease.
What it does
- TEVA-VALGANCICLOVIR works by slowing the growth of CMV virus, the virus that causes CMV retinitis as well as CMV infection at other sites in the body. For most people with CMV retinitis, TEVA-VALGANCICLOVIR prevents CMV from progressing (spreading) into healthy cells as quickly as it would without treatment, thereby protecting eyesight from damage due to CMV disease.
- TEVA-VALGANCICLOVIR does not cure CMV retinitis, and some people may experience progression of retinitis during or following treatment with TEVA-VALGANCICLOVIR. Therefore, you must follow your doctor’s advice and have your eyes checked regularly.
- For most patients who have received a solid organ transplant, TEVA-VALGANCICLOVIR prevents the occurrence of CMV disease up to 6 months after the transplant.
- TEVA-VALGANCICLOVIR is a prodrug of ganciclovir. This means it is changed to ganciclovir once it is absorbed into the body. Ganciclovir is the active part of the drug that actually slows the growth of CMV virus.
When it should not be used
Do not take TEVA-VALGANCICLOVIR if you have ever had a
serious reaction to valganciclovir, ganciclovir (as TEVAVALGANCICLOVIR or ganciclovir capsules or
CYTOVENE®IV).
Do not take if you have had sensitivity reactions with acycloviror
its pro-drug valacyclovir as a similar reaction can occur with
TEVA-VALGANCICLOVIR.
Do not take TEVA-VALGANCICLOVIR if you have any
reaction to any of the non-medicinal ingredients (see “What the
non-medicinal ingredients are”).
What the medicinal ingredient is
The medicinal ingredient found in TEVA-VALGANCICLOVIR is valganciclovir hydrochloride.
What the non-medicinal ingredients are
TEVA-VALGANCICLOVIR tablets contain the following nonmedicinal ingredients: Colloidal anhydrous silica, crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, titanium dioxide and triacetin.
What dosage form it comes in
TEVA-VALGANCICLOVIR is available as a pink 450 mg valganciclovir film-coated tablet (as valganciclovir hydrochloride).
Warnings and precautions
Serious Warnings and Precautions
- Serious blood problems can occur such as low numbers of white blood cells, red blood cells or platelets. (See Side Effects and What to Do About Them)
- 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 TEVA-VALGANCICLOVIR talk to your doctor or pharmacist if:
- you have ever had a bad reaction to TEVAVALGANCICLOVIR (valganciclovir) or any of the inactive ingredients shown above.
- you have ever had a bad reaction to ganciclovir, acyclovir or valacyclovir.
- you are allergic to other medicines, food and dyes.
- you are taking ANY other medicines (prescription or nonprescription) including herbal or natural products.
- you have any other illnesses/diseases, including a history of liver or kidney disease.
- you are receiving hemodialysis as dosage adjustment is required.
- you have blood problems or have abnormal results on your blood tests.
- you are breast-feeding or planning to breast feed. You should not take TEVA-VALGANCICLOVIR while breastfeeding. Women who are HIV positive should not breast feed because HIV infection can be passed to the baby via the breast milk.
Tell your doctor if you are pregnant or planning to become pregnant.
TEVA-VALGANCICLOVIR may cause birth defects in humans and should not be used during pregnancy.
If you are a woman of child-bearing potential then you should:
- avoid pregnancy
- use effective contraception during treatment and for 30 days after stopping treatment
- effective contraception includes:
- a barrier method ( e.g. condom) and
- an additional method ( e.g. birth control pills, intrauterine device)
- use a barrier method (e.g. condom) during treatment and for 90 days after stopping treatment, unless it is certain that the female partner is not at risk of becoming pregnant.
Interactions with this medication
Tell your doctor or pharmacist about all medications that
you are taking, including those you buy over the counter and
herbal or natural products. TEVA-VALGANCICLOVIR may
change the effect of other medications.
Tell your doctor if you are taking any of the following drugs:
- that reduce your immunity such as cyclosporine, tacrolimus, mycophenolate mofetil
- that act against tumours such as vincristine, vinblastine, doxorubicin, hydroxyurea
- that fight infections such as trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine
- pegylated interferons with ribavirin
- Videx® (didanosine, ddI)
- Retrovir® (zidovudine, ZDV, AZT)
- BenurylTM (probenecid)
Proper use of this medication
Dosing Considerations:
- Your doctor has prescribed TEVA-VALGANCICLOVIR after carefully studying your case. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours. Do not give your TEVA-VALGANCICLOVIR to anyone else.
- To make sure that your therapy is as effective as possible, take your TEVA-VALGANCICLOVIR exactly as your doctor prescribes it. Do not skip any doses, or take more than the recommended dose.
- Take TEVA-VALGANCICLOVIR with food.
- Do not break or crush TEVA-VALGANCICLOVIR tablets. Avoid contact with broken TEVAVALGANCICLOVIR tablets on your skin, mucous membranes or eyes. If contact occurs, wash your skin well with soap and water or rinse your eyes well with sterile or plain water if sterile water is not available.
Usual Dose
Treatment of CMV Retinitis in Patients with HIV
- The usual dosage for adults to get active CMV retinitis under control (induction therapy) is two 450 mg tablets twice a day for 21 days.
- The usual dosage for adults to help keep CMV retinitis under control (maintenance therapy) is two 450 mg tablets once a day
- The usual dosage to prevent CMV in adults who received a solid organ transplant is two 450 mg tablets once a day starting within 10 days of transplant and continuing until 100 days after the transplant.
Overdose
Missed Dose
- If you forget to take a dose of TEVA-VALGANCICLOVIR take it as soon as possible, then just carry on with the regular times you take your medication. If you remember your missed dose close to the time for your next dose, do not take the missed dose. Two doses of TEVA-VALGANCICLOVIR should not be taken at the same time.
- Do not let your TEVA-VALGANCICLOVIR run out. The amount of virus in your blood may increase if your medicine is stopped, even for a short time.
- It may be a good idea to ask your doctor or pharmacist ahead of time what to do about missed doses.
Side effects and what to do about them
Unwanted effects are possible with all medicines. Tell your doctor
or pharmacist as soon as possible if you do not feel well while you
are taking TEVA-VALGANCICLOVIR.
Blood problems. TEVA-VALGANCICLOVIR can cause serious
blood cell problems. These include reduced numbers of certain
white blood cells (granulocytopenia, neutropenia, or leukopenia),
reduced numbers of red blood cells (anemia), and reduced numbers
of platelets (thrombocytopenia). TEVA-VALGANCICLOVIR
may also cause blood creatinine elevation, increased potassium in
the blood, and abnormal liver function. Your doctor should
recommend that you have blood tests done on a regular basis.
Kidney problems. TEVA-VALGANCICLOVIR can cause an
increase in serum creatinine (an indicator of kidney function). An
increase in serum creatinine may indicate abnormal kidney
function. Your doctor may have blood tests done on a regular basis
to monitor your serum creatinine.
Common side effects. TEVA-VALGANCICLOVIR can cause
other side effects. In studies, the most common side effects with
the use of valganciclovir hydrochloride (although not necessarily
related to valganciclovir hydrochloride) were diarrhea, nausea,
vomiting, fever, headache, trembling, graft rejection, swelling of
the legs, constipation, back pain, insomnia (sleeplessness), high
blood pressure.
Other side effects. Seizures, dizziness, ataxia (unsteadiness)
and/or confusion have also been reported with the use of
valganciclovir hydrochloride. If they occur, these side effects may
affect a person’s ability to drive a car or operate machinery.
Although there is no supporting information from clinical trials in
humans, animal studies indicate that valganciclovir hydrochloride
may cause cancer and infertility in humans
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
Blood Problems
|
✔ | ||
| Uncommon | |||
Kidney Problems
|
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-VALGANCICLOVIR, contact your doctor or pharmacist.
How to store
- Keep out of the reach and sight of children.
- Store TEVA-VALGANCICLOVIR tablets in a clean dry area at room temperature (15-30°C).
- Keep container tightly closed.
- Do not use medication after the expiry date on the package.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
REMINDER: This medicine has been prescribed only for you.
Do not give it to anybody else. If you have any further questions,
please ask your doctor or pharmacist.
If you want more information about TEVA-VALGANCICLOVIR:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268- 4127 ext. 3; or email druginfo@tevacanada.com.
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
Last revised: June 7, 2019
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