Patient Medication Information: uses, side effects, how to take - Vocarvi
What is Vocarvi™ used for?
Vocarvi™ is a brand name for the drug "foscarnet sodium". It is an antiviral agent which is injected. Vocarvi™ is usually used to treat retinitis (inflamed condition of the eye) caused by cytomegalovirus (CMV) in patients who have acquired immunodeficiency syndrome (AIDS). Vocarvi™ can also be used to treat acyclovir-resistant mucocutaneous herpes simplex virus in patients who are immunocompromised (have a weak immune system).
How does Vocarvi™ work?
Vocarvi™ interferes with the way viral cells reproduce themselves. This stops the virus from increasing in number.
What are the ingredients in Vocarvi™?
Medicinal ingredient: Foscarnet sodium hexahydrate
Non-medicinal ingredients: Hydrochloric acid to adjust pH, Water for injection
Vocarvi™ comes in the following dosage forms:
Solution for injection, 24 mg/mL
Serious Warnings and Precautions
Vocarvi can cause serious kidney problems. This risk may be increased if you already have existing kidney problems. It is important to drink plenty of fluids when receiving Vocarvi™. Your doctor will order blood tests to monitor your kidney function and may change how you are receiving Vocarvi. Your doctor will also monitor your kidney function if you are taking other drugs that can cause kidney problems.
- Vocarvi can cause irregular heart beats. The is risk may be increased if you already have existing heart conditions. Tell your doctor if you have any heart conditions.
- Vocarvi can decrease the level of minerals (called electrolytes) such as calcium and magnesium in your blood. Your doctor will order tests to assess the level of minerals in your blood before and while you are receiving Vocarvi.
Vocarvi can cause seizures. This may be related to the level of minerals in your blood.
Your doctor will monitor this and may give you mineral supplements while you are receiving Vocarvi.
Do not use Vocarvi™ if:
If you have ever received Vocarvi™ before and have experienced an allergic reaction to its use or if you know that you are allergic to any of the ingredients listed in this leaflet (see What are the ingredients in Vocarvi™).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vocarvi™. Talk about any health conditions or problems you may have, including if you:
- Have breathing or heart problems, or if you have been generally unwell for some time;
- Have kidney problems;
- Have liver problems;
- Are receiving hemodialysis;
- Have low numbers of either white blood cells, red blood cells, or platelets in your blood;
- Have abnormal levels of minerals (called electrolytes) in your blood;
- Are taking any other medicines (prescription or non-prescription);
Are pregnant, plan to become pregnant or are breastfeeding. It is not known if Vocarvi passes in your breast milk.
Other Warnings you should know about:
Sexual Health:
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 Vocarvi™.
Female patients
- Use barrier protection (condoms) and one additional form of contraception (birth control pills, intrauterine device) during treatment with Vocarvi™.
Male patients
- Use barrier protection (condoms) during and for at least 6 months following treatment with Vocarvi™, unless it is certain that the female partner is not at risk of pregnancy.
Driving and using machines:
While receiving Vocarvi, you may feel dizzy, sleepy, or you may have seizures. Try to avoid driving a vehicle or using machinery while you are receiving Vocarvi.
Lab tests:
Your doctor will order blood tests for you while you are receiving Vocarvi. This will help assess your kidney functions and the level of minerals (called electrolytes) in your blood. Your dose of Vocarvi will be adjusted if needed.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Vocarvi™:
- Pentamidine (used for infections).
- Loop diuretics (used to help treat high blood pressure).
- Amphotericin B (used for fungal infections).
- Aciclovir (used for viral infections).
- Antibiotics called aminoglycosides, such as gentamicin and streptomycin (used for infections).
- Ciclosporin A, methotrexate or tacrolimus (used to suppress the immune system).
- Medicines called protease inhibitors, such as ritonavir and saquinavir.
- Laxatives.
- Quinidine, amiodarone, sotalol or any other medicines which may affect your heart rate or rhythm.
- Tranquilisers (neuroleptics).
How to take Vocarvi™:
Vocarvi™ will be given to you by a healthcare professional. It will be given to you as an infusion (drip) into a vein. It may be given into a central line in your chest if you already have one in place.
Each infusion will take at least 1 hour. Do not interfere with your drip during the infusion.
The amount of Vocarvi™ that you are given depends on how well your kidneys are working. It also depends on your weight.
It is important to have plenty of fluid with the infusion. This will help to prevent kidney problems. If you need fluid, your healthcare professional will give it to you at the same time as Vocarvi™.
Usual dose:
Vocarvi™ for CMV retinitis
If you are having Vocarvi™ to treat CMV retinitis, there will be two stages to your treatment. The first stage is called induction therapy and the second stage is called maintenance therapy.
Induction therapy
- During induction therapy, you will be given an infusion every 8 or 12 hours. This will usually happen for 2 or 3 weeks.
- The usual dose for induction therapy is 60 mg or 90 mg of Vocarvi™ for every kilogram that you weigh (60 mg/kg or 90 mg/kg).
- Your doctor will tell you when you are ready to change to maintenance therapy.
Maintenance therapy
- During maintenance therapy, you will be given an infusion once a day.
- The usual dose for maintenance therapy is 90 to 120 mg of Vocarvi™ for every kilogram that you weigh (90 to 120 mg/kg).
Your doctor will determine the right dose for you. Sometimes your doctor may ask you to have a medicine called ganciclovir as well. This is to make sure that you have the treatment that is right for you.
Having Vocarvi™ for Herpes Simplex Virus
- If you are being given Vocarvi™ to treat Herpes Simplex Virus, there is only one treatment stage.
- You will be given an infusion every 8 hours.
- Your wounds (lesions) may start to heal after about 1 week. However, you may need to keep having Vocarvi™ for 2 to 3 weeks or until your wounds have healed.
- The usual dose is 40 mg of Vocarvi™ for every kilogram that you weigh (40 mg/kg).
Overdose:
If you think you have been given too much Vocarvi™, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using Vocarvi™?
These are not all the possible side effects you may feel when taking Vocarvi™. If you experience any side effects not listed here, contact your healthcare professional.
Side effects include:
- Fever
- Nausea
- Diarrhea
- Vomiting
- Loss of appetite
- Feeling very thirsty
- Headache
- Dizziness
- Fatigue
- Feeling cold followed by a rise in temperature (rigors)
- Feeling weak or tired
- Muscle twitching
- Prickling sensation
- Reduced feeling in the skin (numbness) and tingling
- Coughing
- Shortness of breath
- Chest pain
- Rash, itchy skin
- Swelling, pain and redness along a vein or where the injection needle is inserted
- Increased sweating
- Changes in your vision
- Swelling of the feet or legs
- Genital sores
Vocarvi can cause abnormal test results. This includes high or level of minerals and sugar in your blood. Your healthcare professional will order some tests before and during your treatment. These include blood tests to monitor your kidney function and minerals (electrolytes) in your body. Your healthcare professional will tell you if your test results are abnormal and if you need treatment to correct these side effects.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Anemia: (low levels of red blood cells): tiredness, weakness, fatigue, pale skin | √ | ||
Seizures (fit): loss of consciousness with uncontrollable shaking | √ | ||
| Marrow suppression (a large decrease in the production of blood cells and platelets by the bone marrow): bleeding, bruising, chills, fatigue, fever, weakness, shortness of breath or other signs of infection | √ | ||
| COMMON | |||
| Mental Health Problems: depression, confusion, anxiety | √ | ||
| UNCOMMON | |||
| Cardiovascular Problems (heart and blood vessel problems which can lead to heart failure): difficulty breathing, pounding heartbeat, irregular heartbeat, chest pain, swelling of the stomach, feet, and legs, fatigue, loss of consciousness | √ | ||
Nervous system problems: dizziness, confusion, trouble thinking or focusing, lack of coordination when walking, muscle weakness or involuntary movement, difficulty speaking, paralysis | √ | ||
| Gastrointestinal problems (stomach problems): constipation, severe stomach pain, indigestion, vomiting blood | √ | ||
| Hepatitis (Inflammation of liver): abdominal pain, fatigue, fever, itchiness, light coloured stool, trouble thinking clearly, yellowing of the skin (Jaundice) | √ | ||
| Lung problems: cough (may cough with blood), shortness of breath, chest pain or discomfort, wheezing when breathing, stomach bleeding, difficulty breathing when lying down | √ | ||
| Kidney problems: fatigue, pain in the lower back, pain when you pass urine, blood in urine, change in how often you pass urine, gain in weight (due to fluid retention) | √ | ||
| UNKNOWN | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing; | √ | ||
| vomiting; hives or rash; swelling of the face, lips, tongue or throat. | |||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
Stevens-Johnson syndrome (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||
Toxic Epidermal Necrolysis (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid pulse, nausea, vomiting, tenderness when touching the abdomen | √ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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.
Storage:
Keep out of reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Vocarvi™ Store at 15°C - 30°C. Do not refrigerate.
Do not throw away any medicines via wastewater or household waste. Ask your health care professional how to throw away medicines you no longer use. These measures will help protect the environment.
If you want more information about Vocarvi™:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.sterimaxinc.com, or by calling 1-800-881-3550.
SteriMax Inc.
2770 Portland Dr.
Oakville, ON L6H 6R4