Patient Medication Information: uses, side effects, how to take - Melphalan for Injection (Auro Pharma)
Serious Warnings and Precautions
Melphalan for Injection should only be prescribed by a healthcare professional experienced in the use of anti-cancer drugs.
The following serious side effects have been seen in patients taking Melphalan for Injection:
- Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fast heartbeat.
- Bone Marrow Suppression: signs and symptoms of infections (including fever, chills, sore throat, mouth ulcers), fatigue, easy bruising, bleeding of the nose, gums or mouth, tiny red spots on the skin, rash, shortness of breath, pale skin lips and nail beds.
- Lung Problems Causing Death: suddenly worsening shortness of breath, wheezing, tiredness, possibly with a cough or fever, painful breathing.
- Infertility in both men and women.
- Birth defects in babies whose mother or father was taking Melphalan for Injection.
- Development of new cancers, other than the cancer you are being treated for.
What is Melphalan for Injection used for?
Melphalan for Injection is used in adults:
- to relieve symptoms caused by multiple myeloma, a cancer of the blood
- to relieve symptoms caused by a type of ovarian cancer (epithelial carcinoma of the ovary) that cannot be removed by surgery
- together with surgery to treat skin cancer (malignant melanoma)
How does Melphalan for Injection work?
Melphalan for Injection belongs to a group of anti-cancer medicines called antineoplastic alkylating agents. These medications work by stopping cancer cells from dividing and growing.
What are the ingredients in Melphalan for Injection:
Medicinal ingredient: Melphalan (as melphalan hydrochloride).
Non-medicinal ingredients: Hydrochloric acid, Povidone.
Each vial contains 10 mL buffer solution contains the following important non-medicinal ingredients: ethanol, sodium citrate, propylene glycol and water for injection.
Melphalan for Injection comes in the following dosage forms:
Injection (Lyophilized): 50 mg / vial
Do not use Melphalan for Injection if:
- you are allergic to melphalan, chlorambucil or any of the other ingredients in Melphalan for Injection.
- your disease has not responded to Melphalan for Injection treatment.
- you are currently receiving or have recently received radiotherapy or chemotherapy.
- you have been recently treated with medicines similar to Melphalan for Injection.
- you have low neutrophil or platelet counts (neutrophils and platelets are blood cells).
- you are breastfeeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Melphalan for Injection. Talk about any health conditions or problems you may have, including if you:
- have recently been vaccinated, or are planning to be vaccinated with a live vaccine.
- have kidney disease.
Other warnings you should know about:
Development of new cancers
- Melphalan has been reported to cause new cancers in some patients who have been treated with the drug. If you have any concerns or notice any new symptoms talk to your healthcare professional.
Pregnancy and birth control
Female patients
- If you are pregnant or able to become pregnant, there are specific risks you should discuss with your healthcare professional.
- Avoid becoming pregnant during Melphalan for Injection treatment. It may harm your unborn baby.
- You should use effective method of birth control during Melphalan for Injection treatment. Continue using birth control for at least 6 months after stopping treatment, or as advised by your healthcare professional.
If you are taking oral birth control pills, you may need to switch to another birth control method to reduce your risk of getting blood clots in a vein (venous thromboembolism). Talk to your healthcare professional about birth control
- methods that may be right for you.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during Melphalan for Injection treatment.
Male patients
- Avoid fathering a child during Melphalan for Injection treatment and for at least 6 months after stopping treatment.
- You should use effective method of birth control during Melphalan for Injection treatment. Continue using birth control for at least 6 months after stopping treatment, or as advised by your healthcare professional.
- Tell your healthcare professional right away if your partner become pregnant during your treatment with Melphalan for Injection.
- Fertility
- Melphalan for Injection may affect your ability to have a child. If you have any concerns about this, talk to your healthcare professional.
- Surgery
- If you need surgery, tell the healthcare professional or anaesthetist that you are taking Melphalan for Injection.
- Check-ups and testing
- Your healthcare professional will do blood tests before you start treatment with Melphalan for Injection and before each dose.
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 Melphalan for Injection:
- nalidixic acid, an antibiotic used to treat bacterial infections.
- cyclosporine, used to prevent organ rejection in people who have had an organ transplant.
- busulfan, used to treat cancer.
- vaccination with live vaccines.
How to take Melphalan for Injection:
Melphalan for Injection will be given to you by a specially trained doctor or nurse. They will use one of the two methods:
- with a needle directly into a vein (IV), or
- Into an artery (intra-arterial perfusion)
Usual adult dose:
Your healthcare professional will decide on your dose based on your weight and height. Your dose may change based on how well you are responding to treatment and your blood test results.
Thromboembolic events
- You should receive prophylaxis of venous thromboembolism (blood clots in a vein) for at least the first 5 months of treatment especially if you have additional thrombotic risk factors. Your healthcare professional will decide what measures should be taken after careful assessment of your underlying risk factors.
- Your healthcare professional will stop your Melphalan for Injection treatment if you experience blood clots. If you have any symptoms of blood clots during treatment, tell your healthcare professional right away.
If Melphalan for Injection is stopped, your healthcare professional will:
- give you treatment with anticoagulants (medicines that help prevent blood clots). You may need to continue using anticoagulants during Melphalan for Injection treatment.
- tell you when you can restart Melphalan for Injection in combination with other medicines.
Overdose:
If you think you, or a person you are caring for, have been given too much Melphalan for Injection, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss an appointment to receive a dose of Melphalan for Injection contact your healthcare professional as soon as possible.
What are possible side effects from using Melphalan for Injection?
These are not all the possible side affects you may feel when taking Melphalan for Injection. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- In women, periods may stop
- In men, sperm production may be reduced or stopped
- Nausea, vomiting, diarrhea
- Mouth ulcers or sores
- Hair loss
- Skin rash and/or itching
- Mild pain and/or irritation where Melphalan for Injection was injected
- Flushing, feelings of warmth and/or tingling
- Muscle pain, wasting, or scarring
Melphalan for Injection can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
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 | ||||||
Bone Marrow Suppression: signs and symptoms of infections (including fever, chills, sore throat, mouth ulcers), fatigue, easy bruising, bleeding of the nose, gums or mouth, tiny red spots on the skin, rash, shortness of breath, pale skin lips and nail beds | X | |||||
| COMMON | ||||||
| Compartment Syndrome: pain, pale skin, numbness, tingling and weakness or paralysis in the leg or arm where Melphalan for Injection was injected | X | |||||
| RARE | ||||||
| Allergic Reaction: swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, rash, hives, fast heartbeat | X | |||||
| Liver Problems: yellowing of the whites of eyes or the skin, dark urine, abdominal pain, nausea, vomiting, loss of appetite | X | |||||
| Lung Problems (interstitial lung disease, pneumonitis): fatal and serious with suddenly worsening shortness of breath, wheezing, tiredness, possibly with a cough or fever, painful breathing | X | |||||
| Injection Site Reaction: severe muscle or nerve damage, pain, redness, inflammation, | X | |||||
| tenderness, ulcers or infection at the injection site that can lead to amputation | ||||||
| UNKNOWN | ||||||
Rhabdomyolysis (severe muscle breakdown): muscle weakness, fatigue, soreness, bruising, fever, passing little or no urine, tea-coloured urine | X | |||||
| Kidney Problems: acute kidney injury (severe kidney problems), confusion, itchiness or rashes, puffiness in your face and hands, swelling in your feet or ankles, urinating less or not at all, weight gain. | X | |||||
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Melphalan for Injection should be stored at controlled room temperature (15°-30°C).
- Protect from light.
- Keep out of reach and sight of children.
If you want more information about Melphalan for Injection:
- 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 Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-
- products/drug-products/drug-product-database.html ); the manufacturer’s website http://www.auropharma.ca or by calling 1-855-648-6681.