For Patients

Lenvima® (lenvatinib mesilate) is an unfunded Prescription Medicine (a prescription charge and normal doctor’s charges will apply). Available in 4 mg and 10 mg hard capsules. Lenvima is used to treat liver cancer (hepatocellular carcinoma), and thyroid cancer in adults when radioactive iodine treatment has not helped stop the disease. It is also used to treat patients with advanced kidney cancer (advanced renal carcinoma) where treatment can be given in either combination with the medicine pembrolizumab as first treatment when the kidney cancer has spread or cannot be removed by surgery; or in combination with the medicine everolimus after one course of treatment with another anticancer medicine. It is also used to treat a type of uterine cancer called endometrial carcinoma in combination with the medicine pembrolizumab in patients when other treatments have not helped stop the disease. Lenvima should not be taken if you are allergic to Lenvatinib, the active ingredient, or to any of the other ingredients listed in the Consumer Medicine Information (CMI); or if you are breast-feeding. Lenvima should be used with caution in patients who: have high blood pressure; have a history of heart problems or stroke; are over 65 years of age; have had recent surgery or radiotherapy; have liver or kidney problems. Lenvima is not recommended for use in children and teenagers. Very common side effects include high or low blood pressure; loss of appetite or weight loss, feeling sick and being sick, constipation, diarrhoea, stomach pain, indigestion; feeling sleepy (drowsiness or somnolence); feeling very tired or weak; cough or hoarse voice; swelling of the legs; rash; dry, sore or inflamed mouth, odd taste sensation; swelling and inflammation of the joints, and stiff muscles, bones and joints; feeling dizzy; hair loss; bleeding (most commonly nose bleeds); trouble sleeping; increased protein in the urine; urinary infections; pain (muscle, joint, headache, back); redness, soreness and swelling of the skin on the hands and feet; underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin); low levels of potassium and calcium in blood tests; high levels of cholesterol, thyroid stimulating hormone, lipase and amylase enzymes (digestive), creatine levels (kidney function) in blood tests; decreases in the number of white blood cells; bruising and difficulty wound healing, changes in blood test results for liver function. Lenvima has risks and benefits. Use strictly as directed. Ask your doctor if Lenvima is right for you. If symptoms continue or you have side effects, see your doctor, pharmacist or healthcare professional. For more information on Lenvima including side effects see the CMI at www.medsafe.govt.nz or speak with your doctor. TAPS DA 2263MR. 0522.

Fycompa® (perampanel) is an unfunded Prescription Medicine (a prescription charge and normal doctor’s charges will apply). Available as film-coated tablets (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg) or as an oral suspension (2 mg/4 mL). Fycompa is used to treat certain forms of epilepsy. In adults, adolescents and children aged 4 years and older it is used to treat fits that affect one part of the brain (called a “partial seizure”, (POS)). These partial seizures may or may not then be followed by a fit affecting all of the brain (called a “secondary generalisation”). In adults, adolescents and children aged 7 years and older it is also used to treat certain fits that affect all of the brain from the start and cause convulsions (called “primary generalised tonic-clonic seizures”, (PGTCS)). It works by reducing the number of fits that you or your children have. Fycompa should not be taken if you or your child have an allergy to perampanel (the active ingredient), or to any of the other ingredients listed at the end of the Consumer Medicine Information (CMI) leaflet. Fycompa is not recommended for children under 4 years of age for partial seizures and under 7 years of age for primary generalised tonic-clonic seizures. Fycompa should be used with caution in: patients with a history of drug abuse; patients aged 65 years or older (high rates of dizziness and falls); patients with a history of severe mental conditions or aggression. Serious or life-threatening psychiatric and behavioural adverse reactions including aggression, hostility, irritability, anger, suicidal ideation and homicidal ideation and threats have been reported in patients taking Fycompa. If changes in behaviour or personality are seen notify your doctor immediately. Fycompa film coated tablets contain lactose. If you have been told by your doctor that you or your child have intolerance to some sugars, tell your doctor before taking it. Fycompa oral suspension contains sorbitol and benzoates. If you have been told by your doctor that you or your child have intolerance to these, tell the doctor before taking it.  Fycompa is not recommended in pregnancy. You must use a reliable method of contraception while being treated with Fycompa. If you or your child become pregnant while taking Fycompa, tell your doctor immediately. It is not known whether the ingredients of Fycompa can pass into breast milk (your doctor can weigh up the benefit and risks to you or your baby of taking Fycompa while you are breastfeeding). Do not drive or operate machinery until you know how Fycompa affects you. Avoid alcohol while taking Fycompa. If you or your child are going to have surgery, tell the surgeon or anaesthetist that you or your child are taking Fycompa. If you or your child are about to have any blood tests, tell your doctor that you or your child are taking Fycompa. Tell your doctor if you or your child are taking hormonal contraceptives. Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective. Tell your doctor or pharmacist if you or your child are taking any other medicines, including any that you or your child get without a prescription from the pharmacy, supermarket or health food shop; some medicines and Fycompa may interfere with each other. These include: carbamazepine, phenytoin, oxcarbazepine; rifampicin, hypericum (St. John’s wort), felbamate, ketoconazole, oral contraceptives. Tell your doctor if you have liver problems, moderate or severe kidney problems, a history of alcoholism, drug dependence or other psychiatric illness. Very common side effects include feeling dizzy, feeling sleepy (drowsiness or somnolence). Common side effects include increased or decreased appetite, weight gain; feeling aggressive, angry, irritable, anxious or confused; difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder); slow speech (dysarthria); blurred vision or double vision (diplopia); spinning sensation (vertigo); feeling sick (nausea); back pain; feeling very tired (fatigue); falling down. If you or your child get a skin rash, or fever, and/or enlarged lymph nodes, these could be signs of an allergic reaction. See your doctor immediately as very occasionally this may become serious. Fycompa has risks and benefits. Use strictly as directed. Ask your doctor if Fycompa is right for you or your child. If symptoms continue or if you or your child have side effects, see your doctor, pharmacist or healthcare professional. For more information on Fycompa including side effects see the CMI at www.medsafe.govt.nz or speak with your doctor. TAPS DA 2263MR. 0321.

Inovelon® (rufinamide) is an unfunded Prescription Medicine (a prescription charge and normal doctor’s charges will apply). Available as film-coated tablets (200 mg and 400 mg). Inovelon is used with other medicines to treat seizures associated with Lennox Gastaut syndrome in adults, adolescents and children from 4 years of age. It works by reducing the number of fits that you have. Inovelon should not be taken if you have an allergy to rufinamide (the active ingredient), or to any of the other ingredients listed at the end of the Consumer Medicine Information (CMI) leaflet. Inovelon tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, tell your doctor before taking Inovelon. Tell your doctor if you have or have had any of the following medical conditions: congenital short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), heart problems, liver problems, have or have had suicidal thoughts or actions, depression or mood problems. Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. You must only take Inovelon during your pregnancy if the doctor tells you to. A reliable method of contraception must be used to avoid becoming pregnant while being treated with Inovelon, and should be continued for one month after stopping Inovelon. Tell your doctor if you are taking hormonal contraceptives. Inovelon may make certain hormonal contraceptives less effective. You should use other forms of safe and effective contraception (such as a condom or coil) when taking Inovelon. It is not known whether the ingredients of Inovelon can pass into breast milk. Your doctor will weigh up the benefit and risks to your baby of taking Inovelon while you are breastfeeding. Tell your doctor if you are taking any other medicines, including any that you get without a prescription from the pharmacy, supermarket or health food shop; some medicines and Inovelon may interfere with each other. These include carbamazepine, phenobarbital, phenytoin, vigabatrin, primidone. Tell your doctor if you are taking warfarin (a blood thinner), or digoxin (a medicine used to treat heart conditions). Tell your doctor you are taking Inovelon if they prescribe or recommend any additional treatment for epilepsy (e.g. valproate). Tell any other doctors, dentists and pharmacists who treat you that you are taking Inovelon. If you are going to have surgery, tell the surgeon or anaesthetist that you are taking Inovelon. If you are about to have any blood tests, tell your doctor that you are taking Inovelon. Do not drive or operate machinery until you know how Inovelon affects you. Avoid alcohol while taking Inovelon. Very common side effects include dizziness, headache, nausea, vomiting, sleepiness, fatigue. Common side effects include problems associated with nerves including difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling; problems associated with the stomach including stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss; infections including ear infection, flu, nasal congestion, chest infection. A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor or go to accident & emergency straight away. The following side effects can be very serious and you should tell your doctor immediately or go to a hospital if you experience any of them: rash and/or fever (these could be signs of an allergic reaction); change in the types of seizures you experience or if you experience more frequent seizures which last a long time (called status epilepticus). Inovelon has risks and benefits. Use strictly as directed. Ask your doctor if Inovelon is right for you. If symptoms continue or if you have side effects, see your doctor, pharmacist or healthcare professional. For more information on Inovelon including side effects see the CMI at www.medsafe.govt.nz or speak with your doctor. TAPS DA 2263MR. 0421.

Lenvima®, Fycompa® and Inovelon® are registered trademarks of the Eisai Group, whose affiliate company in New Zealand is Eisai New Zealand Limited, c/o Simpson Grierson, Level 27, 88 Shortland Street, Auckland Central, Auckland, 1010.