Auro-Valganciclovir: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• AURO-VALGANCICLOVIR is a prescription

  medication that belongs to the family of drugs known as “antivirals”.

• AURO-VALGANCICLOVIR is used to treat

  cytomegalovirus (CMV) retinitis in adults who have acquired immunodeficiency syndrome (AIDS).

• AURO-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:

• AURO-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, AURO-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.

• AURO-VALGANCICLOVIR does not cure CMV

  retinitis, and some people may experience progression of retinitis during or following treatment with AURO-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, AURO-VALGANCICLOVIR prevents the occurrence of CMV disease up to 6 months after the transplant.

• Valganciclovir hydrochloride 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 AURO-VALGANCICLOVIR if you have ever had a serious reaction to valganciclovir, ganciclovir (as valganciclovir hydrochloride or ganciclovir capsules or Ganciclovir Sodium for Injection).

Do not take if you have had sensitivity reactions with acyclovir or its pro-drug valacyclovir as a similar reaction can occur with AURO-VALGANCICLOVIR.

Do not take AURO-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:

valganciclovir hydrochloride.

What the non-medicinal ingredients are: AURO-VALGANCICLOVIR tablets contain the following nonmedicinal ingredients: cellulose microcrystalline, crospovidone, povidone and magnesium stearate

Opadry Pink YS-1-14519A:

It contains hypromellose, titanium dioxide, polysorbate 80, polyethylene glycol and iron oxide red.

What dosage forms it comes in:

AURO-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 AURO-VALGANCICLOVIR talk to your doctor or pharmacist if:

• you have ever had a bad reaction to AURO-

  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 AURO-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.

Pregnancy:

Tell your doctor if you are pregnant or planning to become pregnant.

AURO-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 AURO-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 AURO-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 AURO-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. AURO-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 AURO-

VALGANCICLOVIR:

• Videx^® (didanosine, ddI)
• Retrovir^® (zidovudine, ZDV, AZT)
• Benuryl^TM (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 AURO-

  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 AURO-VALGANCICLOVIR to anyone else.

• To make sure that your therapy is as effective as possible, take your AURO-VALGANCICLOVIR exactly as your doctor prescribes it. Do not skip any doses, or take more than the recommended dose.

• Take AURO-VALGANCICLOVIR with food.

• Do not break or crush AURO-

  VALGANCICLOVIR tablets. Avoid contact with broken AURO-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:

If you think you have taken too much AURO-VALGANCICLOVIR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

• If you forget to take a dose of AURO-

  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 AURO-VALGANCICLOVIR should not be taken at the same time.

• Do not let your AURO-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 AURO-VALGANCICLOVIR.

Blood problems. AURO-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). AURO-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. AURO-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. AURO-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.

This is not a complete list of side effects. For any unexpected effects while taking AURO-VALGANCICLOVIR, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep out of the reach and sight of children.
• Store at room temperature (15°C to 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 side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

products/medeffect-canada.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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

If you want more information about AURO-VALGANCICLOVIR:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://

  www.auropharma.ca, or by calling 1-855-648-6681.

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8,

Canada.

Date of Revision: March 14, 2018