Targretin
bexarotene
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Targretin is and what it is used for
What you need to know before you take Targretin
How to take Targretin
Possible side effects
How to store Targretin
Contents of the pack and other information
The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A.
Targretin capsules are used by patients with advanced stage cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies. CTCL is a condition in which certain cells of the body’s lymph system called T-lymphocytes become cancerous and affect the skin.
if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breast feeding or if you can become pregnant and are not using effective
birth control measures.
if you have a history of pancreatitis, have uncontrolled lipid (blood fats) elevations (high blood cholesterol or high blood triglycerides), have a condition known as hypervitaminosis A, have uncontrolled thyroid disease, have insufficient liver function or have an ongoing systemic infection.
Talk to your doctor before taking Targretin
if you have a known hypersensitivity to retinoids (related to vitamin A), suffer from liver disease, have high blood lipids or take medicines which may cause high blood lipids, have uncontrolled diabetes mellitus (sugar diabetes), have had gall bladder or biliary tract disease, or consume excessive amounts of alcohol.
if you have ever had any mental health problems including depression, aggressive tendencies or mood changes. This is because taking Targretin may affect your mood.
Your fasting blood lipid determinations may have to be performed before therapy is initiated and at weekly intervals afterwards, and then monthly while taking this medicine.
Blood tests to evaluate the function of your liver and thyroid gland and to monitor your red blood cell and white blood cell counts will be obtained before therapy is started and will be monitored during therapy.
Periodic eye exams may be needed if you experience visual difficulties while taking this medicine. Minimise exposure to sunlight as much as possible and avoid exposure to sun lamps.
Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.
Mental health problems
You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour. They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Targretin capsules should not be used in children or adolescents.
Tell your doctor if you are taking, have recently taken or might take any other medicines, such as
ketoconazole and itraconazole (used against fungal infections),
erythromycin, clarithromycin and rifampicin (used against bacterial infections),
phenytoin and phenobarbital (used against seizures),
gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
vitamin A supplements, protease inhibitors (used against viral infections),
tamoxifen (used against some forms of cancer),
dexamethasone (used for inflammatory conditions),
insulin, agents enhancing insulin secretion, or insulin-sensitisers (used against diabetes mellitus).
This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Targretin should be taken with food (see section 3). If you regularly consume grapefruit or grapefruit
juice, please consult your doctor as these have the potential to alter your body’s response to Targretin therapy.
Targretin may be harmful to a developing foetus. DO NOT use Targretin if you are pregnant or
breast-feeding. 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 taking this medicine.
If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start therapy, confirming you are not pregnant. You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin. It is recommended that two reliable forms of contraception be used together. If you are taking a hormonal contraceptive (for example, birth control pills), you should discuss this with your doctor.
If you are male and your partner is pregnant or capable of becoming pregnant, you must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.
It is not known whether Targretin has an effect on your ability to drive a car or operate machinery. If
you experience dizziness or problems with your vision during therapy, do not drive or operate machinery.
Targretin contains a small amount of sorbitol (a type of sugar). If you have an intolerance to some
sugars, speak to your doctor before taking this medicinal product.
Butylated hydroxyanisole may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The doctor will prescribe a suitable dose for you.
The recommended dose is generally 4 to 10 capsules to be taken once daily. Take your prescribed number of capsules at the same time each day with a meal. The capsules can be taken immediately before, during or immediately after the course of the meal, if preferred. The capsules should be swallowed whole and not chewed.
Although some patients have improvement within the first several weeks, most patients require several
months or more of treatment to improve.
If you have taken more than the prescribed dose of Targretin, you must contact your doctor.
If you forget to take one dose, take your daily dose with your next meal on the same day, then take
your usual dose as normal, the following day. Do not take a double dose in one day to make up for a forgotten dose the previous day.
Your doctor should determine how long you should take Targretin, and when treatment may be stopped. Do not stop taking your medication until your doctor advises you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor as soon as possible if you feel any deterioration in your condition while you are taking Targretin. Sometimes it is necessary to adjust the dose or interrupt treatment. Your doctor will advise you on what to do.
The following side effects were reported in patients with CTCL who were treated with the recommended initial dose of capsules.
Verycommon(canoccurinmorethan1in10patientstreated): Low white blood cell count.
Lowering of thyroid hormones level.
Elevation of blood fats (triglycerides and cholesterol).
Skin reactions (Itching, redness, irritation, peeling). Headache, fatigue, pain.
Common(canoccurinupto1in10patientstreated):
Low red blood cell count, enlarged lymph nodes, worsening of lymphoma. Thyroid disorder.
Elevation of liver enzymes, impaired kidney function, low protein in blood, weight gain.
Insomnia, dizziness, reduced skin sensation.
Dry eyes, deafness, abnormal sensations of the eye including irritation and heaviness. Swelling of legs and arms.
Nausea, diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excess gas, abnormal liver function tests, vomiting.
Dry skin, skin disorder, loss of hair, skin ulcer, acne, skin thickening, skin nodule, increased sweating. Joint aches, bone pain, muscle aches.
Chills, abdominal pain, allergic reaction, infection.
Uncommon(canoccurinupto1in100patientstreated):
Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets.
Overactive thyroid.
Elevated bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol. Agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, vertigo.
Abnormal vision, blurred vision, inflammation of the eye lids, cataract, inflammation of the white part
of the eye, lesion of the cornea of the eye, ear disorder, defect in field of vision.
Swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels.
Gastrointestinal disorder, liver failure, inflammation of the pancreas.
Changes in hair, herpes simplex, nail disorder, pustular rash, serous drainage, skin discoloration. Muscle weakness.
Proteins in urine, abnormal kidney function.
Back pain, skin infection, fever, parasitic infection, abnormal laboratory test, disorder of mucous membrane, tumour.
Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 label. The expiry date refers to the last day of that month.
Do not store above 30C. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each Targretin capsule contains 75 mg of the active substance bexarotene.
The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole.
The capsule shell consists of gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%).
Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Eisai GmbH
Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
Eisai GmbH
Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
Ewopharma AG atstovybė Tel: +370 5 2430444
Ewopharma AG
Teл.: +359 2 962 12 00
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
(Belgique/Belgien)
Eisai GesmbH organizačni složka
Tel: + 420 242 485 839
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)
Cherubino LTD
Tel: +356 21343270
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
Eisai B.V.
Tel: + 31 (0) 900 575 3340
Ewopharma AG Eesti filiaal Tel: +372 6015540
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)
Arriani Pharmaceutical S.A.
Τηλ: + 30 210 668 3000
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0
Eisai Farmacéutica, S.A.
Tel: + (34) 91 455 94 55
Ewopharma AG Sp. z o.o.
Tel: +48 (22) 620 11 71
Eisai SAS
Tél: + (33) 1 47 67 00 05
Eisai Farmacêtica, Unipessoal Lda
Tel: + 351 214 875 540
Ewopharma d.o.o
Tel: +385 (0) 1 6646 563
Ewopharma AG
Tel: +40 21 260 13 44
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany) Ísland Eisai AB
Sími: + 46 (0)8 501 01 600
(Svíþjóð)
Eisai GesmbH organizačni složka
Tel.: + 420 242 485 839
(Česká republika)
Eisai S.r.l.
Tel: + 39 02 5181401
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi)
Arriani Pharmaceuticals S.A.
Τηλ: + 30 210 668 3000
(Ελλάδα)
Eisai AB
Tel: + 46 (0) 8 501 01 600
Ewopharma AG Pārstāvniecība
Tel: +371 67450497
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)