2 mg film-coated tablets
melphalan
50 mg powder and solvent for injection, solution
melphalan
1. What Alkeran is and what it is used for
Alkeran contains the active substance melphalan. Alkeran belongs to the group of chemotherapy drugs (also known as chemotherapy ) and is used to treat certain types of cancer. It works by inhibiting cell growth and slowing down the continued growth of tumor cells.
Alkeran is used in the treatment of:
- multiple myeloma – cancer that affects a certain type of white blood cell, called plasma cells. Plasma cells help produce antibodies that participate in the body’s immune system.
- advanced ovarian cancer
Ask your doctor if you want more information about these diseases
2. What you need to know before using Alkeran
Do not take Alkeran:
- if you are allergic to melphalan or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Alkeran if:
- you are receiving or have recently received radiation therapy or chemotherapy
- if you have impaired kidney function
- if you are going to be vaccinated or have recently been vaccinated. This is because some so-called live vaccines can give you an infection if you get them while you are being treated with Alkeran.
- if you are taking combined contraceptive pills. This is due to the increased risk of blood clots. You should switch to another effective method of contraception. The risk of blood clots (venous thromboembolism) persists for 4-6 weeks after stopping the use of combined oral contraceptives.
Alkeran may increase the risk of developing other types of cancer. Your doctor will evaluate the benefits and risks of treatment before prescribing Alkeran.
Other medicines and Alkeran
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect or be affected by Alkeran:
- certain vaccines (See Warnings and Precautions)
- nalidixic acid (an antibiotic used to treat infections )
- cyclosporine (used, for example, to prevent organ rejection after a transplant or to treat psoriasis or rheumatism)
- busulfan ( cytostatics )
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There is a risk of fetal harm. Alkeran can harm sperm, eggs, and/or an unborn baby. Reliable contraceptives must be used to avoid pregnancy while you or your partner are taking these tablets.
If you are already pregnant, it is important to tell your doctor before taking Alkeran.
Breast-feeding
Do not breast-feed while you are receiving Alkeran.
Fertility
Alkeran can harm sperm, eggs, and/or an unborn baby.
In women, Alkeran can affect the ovaries, which can lead to infertility (inability to have children), and amenorrhea (missed periods).
In men, Alkeran can affect sperm formation, which can lead to infertility (inability to have children).
It is recommended that men receiving treatment with Alkeran should not become the father of a child during treatment and for up to six months after stopping treatment.
You may want to seek advice on sperm preservation before starting treatment.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharp attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Alkeran
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how many tablets to take and how often to take them. When you take Alkeran, your doctor will take regular blood tests. This is done to control the number of blood cells. This can sometimes lead to your doctor changing your dose.
Multiple Myeloma
The recommended dose is 0.15 mg/kg body weight per day for four days. This treatment is repeated every six weeks.
Ovarian cancer
The recommended dose is 0.2 mg/kg body weight per day for 5 days. This treatment is repeated every four to eight weeks.
Swallow your tablets whole with a glass of water. If the film coating on the tablets is undamaged, there is no risk of adverse effects during handling. The tablets should not be split, crushed, or chewed.
If you forget to take Alkeran:
Inform your doctor. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor or hospital immediately:
• allergic reaction. The characters may include:
– urticaria, pruritus
– swelling of the face, tongue, or throat
– shortness of breath and feeling of tightness in the chest
The allergic reaction has been reported in rare cases (may affect up to 1 in 1,000 people).
• blood effects such as decreased number of red and white blood cells, platelets, or anemia. The characters may include:
– unexpected bruising or bleeding
– abnormal fatigue, dizziness, or shortness of breath
– sudden feeling of illness (even with normal body temperature).
signs of infection such as sore throat
Blood effects have been reported as a very common side effect (may affect more than 1 user in 10).
• blood clot (deep vein thrombosis ), with symptoms such as:
– pain, swelling, and tenderness in the legs, usually in the calf muscles
hot and red skin in the affected area
• blood clot in the lung ( pulmonary embolism ), the symptoms may be one or more of the following:
– chest pain
shortness of breath that may occur suddenly
– cough
– feeling dizzy
– sweating
fainting
Deep vein thrombosis and pulmonary embolism have been reported (occurring in an unknown number of users).
¶
The following side effects may also occur with this medicine:
Very common (may affect more than 1 user in 10) :
- nausea, vomiting, and diarrhea
- inflammation of the mouth ( stomatitis )
- hair loss.
- missed periods in women ( amenorrhea )
Common (may affect up to 1 in 10 people) :
- blood cancer ( leukemia )
- high levels of urea in the blood – in people with kidney damage who are being treated for myeloma.
Rare (may affect up to 1 in 1,000 people):
- lung diseases that can be serious and life-threatening with a dry cough, shortness of breath, and fever (interstitial pneumonitis, pulmonary fibrosis )
- liver effects such as hepatitis or jaundice (yellowing of the whites of the eyes and skin)
- rash, itching.
Has been reported (occurs in an unknown number of users):
- in men: the absence of sperm in the semen ( azoospermia ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Alkeran
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ºC – 8 ºC).
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is melphalan. Each tablet contains 2 mg of melphalan.
- The other ingredients are microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol, titanium dioxide (dye E 171).
What the medicine looks like and the contents of the pack
Alkeran tablets are white to off-white, round, biconvex, and film-coated marked on one side with an “A” and on the other side with “GX EH3”. The tablets are supplied in a brown glass jar with a child-resistant lid containing 25 or 50 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Excella GmbH & Co. KG
Nürnberger Strasse 12,
90537 Moisture,
Germany