Details for: ALKERAN
Company: ASPEN PHARMACARE CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00004715 | ALKERAN | MELPHALAN | 2 MG | TABLET | ORAL |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | KIT | INTRA-ARTERIAL |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | SOLUTION | INTRA-ARTERIAL |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | POWDER FOR SOLUTION | INTRA-ARTERIAL |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | KIT | INTRAVENOUS |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | SOLUTION | INTRAVENOUS |
| 02087286 | ALKERAN | MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION | 50 MG / VIAL; 10 ML / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
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
ALKERAN is indicated 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)
What it does
ALKERAN belongs to a group of anti-cancer medicines called antineoplastic alkylating agents. These medications work by stopping cancer cells from dividing and growing.
When it should not be used
Do not use ALKERAN if:
- you are allergic to melphalan, chlorambucil or any of the other ingredients in ALKERAN.
- your disease has not responded to ALKERAN treatment.
- you are currently receiving or have recently received radiotherapy or chemotherapy.
- you have been recently treated with medicines similar to ALKERAN.
- you have low neutrophil or platelet counts (neutrophils and platelets are blood cells).
- you are breastfeeding
What the medicinal ingredient is
Medicinal ingredient: melphalan.
What the non-medicinal ingredients are
Non-medicinal ingredients:
ethanol, hydrochloric acid (for pH control), povidone, propylene glycol, sodium citrate, water for injection.
What dosage form it comes in
Injection (freeze-dried): 50 mg/vial
Warnings and precautions
Serious Warnings and Precautions
ALKERAN should only be prescribed by a healthcare professional experienced in the use of anticancer drugs.
The following serious side effects have been seen in patients taking ALKERAN:
- 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 ALKERAN.
- Development of new cancers, other than the cancer you are being treated for.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ALKERAN. Talk about any health conditions or problems you may have, including if you:
- are pregnant or likely to become pregnant.
- have recently been vaccinated, or are planning to be vaccinated with a live vaccine.
- have kidney disease.
Other warnings you should know about:
ALKERAN 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.
If you need surgery, tell the healthcare professional or anaesthetist that you are taking ALKERAN.
Your healthcare professional will do blood tests before you start treatment with ALKERAN and before each dose.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural
supplements or alternative medicines.
Interactions with this medication
The following may interact with ALKERAN:
- nalidixic acid, an antibiotic used to treat bacterial infections.
- cyclosporine, used to prevent organ rejection in people who have had an organ transplant.
- busulfan
- vaccination with live vaccines.
Proper use of this medication
How to take ALKERAN injection:
ALKERAN injection will be given to you with a needle, directly into a vein (IV), by a specially trained doctor or nurse.
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 for at least the first 5 months of treatment especially if you have
additional thrombotic risk factors. Your doctor will decide what measures should be taken after careful assessment of your
underlying risk factors.
If you experience any thromboembolic event, tell your doctor immediately as your treatment must be discontinued and a standard
anticoagulation therapy started. Your doctor will decide if you should restart melphalan in combination with lenalidomide and
prednisone or thalidomide and prednisone or dexamethasone once the thromboembolic events have been managed. You should
continue anticoagulation therapy during the course of melphalan treatment.
Overdose
Missed Dose
If you miss an appointment to receive a dose of ALKERAN contact your healthcare professional as soon as possible
Side effects and what to do about them
These are not all the possible side affects you may feel when taking ALKERAN. If you experience any side effects not listed here, contact 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 ALKERAN was injected
- Flushing, feelings of warmth and/or tingling
- Muscle pain, wasting, or scarring
ALKERAN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and and get immediate medical help |
|---|---|---|---|
| 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 | ✔ | ✔ | |
| COMMON | |||
| Compartment Syndrome: pain, pale skin, numbness, tingling and weakness or paralysis in the leg or arm where ALKERAN was injected | ✔ | ||
| Rare | |||
| Allergic Reaction: swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, rash, hives, fast heartbeat | ✔ | ||
| Liver Problems: yellowing of the whites of eyes or the skin, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| 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 | ✔ | ||
| Injection Site Reaction: severe muscle or nerve damage, pain, redness, inflammation, tenderness, ulcers or infection at the injection site that can lead to amputation | ✔ | ||
| NOT KNOWN: | |||
| Severe Muscle Breakdown (rhabdomyolysis): muscle weakness, fatigue, soreness, bruising, fever, passing little or no urine, tea-coloured urine | ✔ | ||
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.
How to store
- ALKERAN injection should be stored at controlled room temperature (15°-30°C).
- Protect from light.
- Keep out of reach and sight of children
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 three ways:
- Report online at www.healthcanada.gc.ca/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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/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
If you want more information about ALKERAN:
- Talk to your healthcare professional
- You may want to read this leaflet again. Please Do Not Throw It Away until you have finished your medicine.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.aspenpharma.ca, or by calling 1-844-330-1213.
This leaflet was prepared by:
Aspen Pharmacare Canada Inc.
Last revised: February 12, 2019
Trademarks are owned by or licensed to the Aspen Group of companies.