Details for: MINT-VALGANCICLOVIR
Company: MINT PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02495457 | MINT-VALGANCICLOVIR | VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) | 450 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- MINT-VALGANCICLOVIR is a prescription medication that belongs to the family of drugs known as “antivirals”.
- MINT-VALGANCICLOVIR is used to treat cytomegalovirus (CMV) retinitis in adults who have acquired immunodeficiency syndrome (AIDS).
- MINT-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
- MINT-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, MINT-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.
- MINT-VALGANCICLOVIR does not cure CMV retinitis, and some people may experience progression of retinitis during or following treatment with MINT-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, MINT-VALGANCICLOVIR prevents the occurrence ofCMV disease up to 6 months after the transplant.
- MINT-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 MINT-VALGANCICLOVIR if you have
ever had a serious reaction to valganciclovir or
ganciclovir (as ganciclovir capsules or ganciclovir
IV).
Do not take if you have had sensitivity reactions with
acyclovir or its pro-drug valacyclovir as a similar
reaction can occur with MINTVALGANCICLOVIR.
Do not take MINT-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
valganciclovir hydrochloride.
What the non-medicinal ingredients are
MINT-VALGANCICLOVIR tablets contain the following non-medicinal ingredients: crospovidone, microcrystalline cellulose, povidone, and stearic acid. The film-coat applied to the tablets contains hydroxypropyl methylcellulose, macrogol, polysorbate 80, red iron oxide, and titanium dioxide.
What dosage form it comes in
MINT-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 MINT-VALGANCICLOVIR talk to your doctor or pharmacist if:
- you have ever had a bad reaction to MINT-VALGANCICLOVIR (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 MINTVALGANCICLOVIR while breastfeeding. Women who are HIV positive should not breast feed because HIV infection can be passed to the baby via the breast milk.
Pregnancy:
Tell your doctor if you are pregnant or planning to
become pregnant.
MINT-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)
If you are a male taking MINT-VALGANCICLOVIR, whose partner is female, then you should:
- 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.
This information will help your doctor and you decide whether you should use MINT-VALGANCICLOVIR and what extra care may need to be taken while you are on the medication. You should always consult your doctor or pharmacist before using other medications while on MINT-VALGANCICLOVIR.
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. MINT-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
The following drugs may need to have their dose changed when taken with MINT-VALGANCICLOVIR:
- Videx® (didanosine, ddI)
- Retrovir® (zidovudine, ZDV, AZT)
- BenurylTM (probenecid)
Imipenem-cilastin - talk to your doctor if you are taking imipenem-cilastin. Seizures have occurred in patients taking imipenem-cilastin and ganciclovir. You may discuss different options with your doctor.
Proper use of this medication
Dosing Considerations:
- Your doctor has prescribed MINT-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 MINT-VALGANCICLOVIR to anyone else.
- To make sure that your therapy is as effective as possible, take your MINT-VALGANCICLOVIR exactly as your doctor prescribes it. Do not skip any doses, or take more than the recommended dose.
- Take MINT-VALGANCICLOVIR with food.
- Do not break or crush MINT-VALGANCICLOVIR tablets. Avoid contact with broken MINT-VALGANCICLOVIR 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.
Prevention of CMV Disease Solid Organ Transplantation
- 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 MINT-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 MINT-VALGANCICLOVIR should not be taken at the same time.
- Do not let your MINT-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 MINT-VALGANCICLOVIR.
Blood problems. MINT-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).
MINT-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. MINT-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. MINT-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 MINTVALGANCICLOVIR. 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
MINT-VALGANCICLOVIR may cause cancer and
infertility in humans.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Blood
Problems -
Reduced
number of white blood
cells
Symptoms
of infection
of the gums,
throat, upper
airways and
skin
include:
chills, fever
(over 100◦F
or 38◦C),
sore mouth,
cough,
redness,
pain or
swelling of
any area of
your body,
or pain or
burning
when you
pass your
urine. -Reduced number of red blood cells Symptoms: tiredness and weakness. -Reduced number of platelets Symptoms: increased bruising and bleeding |
✔ | ||
| Uncommon | |||
| Kidney Problems -Increase in serum creatinine Symptoms: decreased urine output, lower back pain or side pain, or swelling of feet or lower legs. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MINT-VALGANCICLOVIR, contact your doctor or pharmacist.
How to store
- Keep out of the reach and sight of children
- Store MINT-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 3 ways:
- Report online at 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at 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
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
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.
This document plus the full product monograph,
prepared for health professionals can be found at:
www.mintpharmaceuticals.com or by contacting the
sponsor, Mint Pharmaceuticals Inc., at: 1-877-398-
9696
This leaflet was prepared by
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3, Canada
Last Approved: January 2, 2020