Patient Medication Information: uses, side effects, how to take - Mylan-Valganciclovir
ABOUT THIS MEDICATION
What the medication is used for:
- MYLAN-VALGANCICLOVIR is a prescription medication that belongs to the family of drugs known as “antivirals”.
- MYLAN-VALGANCICLOVIR is used to treat cytomegalovirus (CMV) retinitis in adults who have acquired immunodeficiency syndrome (AIDS).
- MYLAN-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:
MYLAN-VALGANCICLOVIR works by slowing the growth of CMV virus, the virus that causes CMV retinitis as well as infection at other sites in the body. For most people with CMV retinitis, MYLAN-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.
- MYLAN-VALGANCICLOVIR does not cure CMV retinitis, and some people may experience progression of retinitis during or following treatment with MYLAN-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, MYLAN-VALGANCICLOVIR prevents the occurrence of CMV disease up to 6 months after the transplant.
- MYLAN-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 MYLAN-VALGANCICLOVIR if you have ever had a serious reaction to valganciclovir, ganciclovir (as MYLAN-VALGANCICLOVIR or ganciclovir capsules or CYTOVENE®-IV). Do not take if you have had sensitivity reactions with acyclovir, ganciclovir and valacyclovir as a similar reaction can occur with MYLAN-VALGANCICLOVIR. Do not take MYLAN-VALGANCICLOVIR if you have any reaction to any of the non-medicinal ingredients (see “What the non-medicial ingredients are”).
What the medicinal ingredient is:
The medicinal ingredient found in MYLAN-VALGANCICLOVIR is valganciclovir hydrochloride.
What the non-medicinal ingredients are:
MYLAN-VALGANCICLOVIR tablets contain the following non-medicinal ingredients: crospovidone, microcrystalline cellulose, purified water and stearic acid. The film-coat applied to the tablets is Opadry® Pink, which contains hydroxypropyl methylcellulose, iron oxide red, polyethylene glycol 400/macrogol, polysorbate 80 and titanium dioxide.
What dosage forms it comes in:
MYLAN-VALGANCICLOVIR is available as a pink 450 mg valganciclovir film-coated tablet (as valganciclovir hydrochloride).
WARNINGS AND PRECAUTIONS
BEFORE you use MYLAN-VALGANCICLOVIR talk to your doctor or pharmacist if:
- you have ever had a bad reaction to MYLAN-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.
you or your partner are pregnant, plan on becoming pregnant, or are breast-feeding a child, as MYLAN-VALGANCICLOVIR 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 for at least 90 days following treatment with MYLAN-VALGANCICLOVIR. For women this means using barrier protection (condoms) and one additional form of contraception (birth control pills, intrauterine device). For men this means using barrier protection (condoms).
Women who are HIV positive should not breast feed because HIV infection can be passed to the baby via the breast milk.
This information will help your doctor and you decide whether you should use MYLAN-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 MYLAN-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. MYLAN-VALGANCICLOVIR may change the effect of other medications.
The following drugs may need to have their dose changed when taken with MYLAN-VALGANCICLOVIR:
- Videx® (didanosine, ddI)
- Retrovir® (zidovudine, ZDV, AZT)
- BenurylTM (probenecid)
Talk to your doctor if you are taking imipenem-cilastin. Convulsions 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 MYLAN-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 MYLAN-VALGANCICLOVIR to anyone else.
- To make sure that your therapy is as effective as possible, take your MYLAN-VALGANCICLOVIR exactly as your doctor prescribes it. Do not skip any doses, or take more than the recommended dose.
Take MYLAN-VALGANCICLOVIR with food.
- Do not break or crush MYLAN-VALGANCICLOVIR tablets. Avoid contact with broken MYLAN-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 AIDS
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:
In case of drug overdose or suspected drug overdose, particularly accidental oral ingestion, contact a healthcare practitioner (e.g. doctor), hospital emergency department, or regional poison control centre, even if there are no symptoms.
Missed Dose:
- If you forget to take a dose of MYLAN-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 MYLAN-VALGANCICLOVIR should not be taken at the same time.
- Do not let your MYLAN-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 MYLAN-VALGANCICLOVIR.
Blood problems. MYLAN-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). MYLAN-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. MYLAN-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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| 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. | √ | ||
HOW TO STORE IT
Common side effects. MYLAN-VALGANCICLOVIR can cause other side effects. In studies, the most common side effects with the use of MYLAN-VALGANCICLOVIR (although not necessarily related to MYLAN-VALGANCICLOVIR) were diarrhea, nausea, vomiting, fever, headache, trembling, graft rejection, swelling of the legs, constipation, back pain, insomnia (sleeplessness), high blood pressure.
Other side effects. Convulsions, sedation, dizziness, ataxia (unsteadiness) and/or confusion have also been reported with the use of MYLAN-VALGANCICLOVIR. 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 MYLAN-VALGANCICLOVIR may cause cancer and infertility in humans.
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-VALGANCICLOVIR, contact your doctor or pharmacist.
Preserve in tight container. Store at 25°C, excursion permitted between 15°C and 30°C.
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada,
Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php)
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document can be found at: www.mylan.ca
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379.
Etobicoke, Ontario M8Z 2S6
Revised on: February 17, 2015
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca