3 mg powder for solution for injection
metreleptin
What Myalepta is and what it is used for
Myalepta contains the active substance metreleptin.
- Metreleptin is similar to a human hormone called leptin.
What Myalepta is used for
Myalepta is used to treat complications caused by leptin deficiency in patients with lipodystrophy.
It is used in adults, adolescents, and children aged 2 years and older:
- who have generalized lipodystrophy (the whole body is deficient in adipose tissue).
It is used, when other treatments have not had sufficient effect, in adults and adolescents aged 12 years and older:
- who have partial hereditary lipodystrophy (also called congenital or familial lipodystrophy)
- or if partial lipodystrophy has been caused by the body’s response to e.g. a viral disease (also called acquired lipodystrophy).
How Myalepta works
Natural leptin is produced by adipose tissue and has many functions in the body, such as:
- controls the feelings of hunger and energy levels
- insulin in the body helps manage sugar levels.
Metreleptin works by mimicking the effects of leptin. This improves the body’s ability to control energy levels.
What you need to know before using Myalepta
Do not use Myalepta
- if you are allergic to metreleptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Myalepta:
- if you are pregnant
- if you have had a type of cancer called lymphoma
- if you have had problems with your blood (such as low blood cell counts )
- if you have had pancreatitis
- if you have or have had problems with the immune system ( autoimmune disease, including autoimmune liver disease).
Lymphoma
People with lipodystrophy can get a type of blood cancer called lymphoma regardless of whether they are using Myalepta.
However, you may have a higher risk of getting lymphoma when you use this medicine.
- Your doctor will decide if you should use Myalepta and monitor you during treatment.
The severe infection you
When you are treated with Myalepta, your body may begin to produce antibodies that may increase the risk of developing severe infections. Tell your doctor immediately if you get a fever followed by increased fatigue (see section 4).
Low blood sugar with insulin or other diabetes medicines
If you are taking a medicine such as insulin or other diabetes medicines, your doctor will monitor your blood sugar closely. Your doctor will change your dose of insulin or other medicines as needed.
The purpose of this is to prevent your blood sugar from getting too low ( hypoglycemia ). For signs of low blood sugar, see section 4 under “Signs of high and low blood sugar”.
High blood sugar and high blood fats
You may have higher levels of sugar (hyperglycemia) or fat ( hypertriglyceridemia ) in your blood during treatment with Myalepta, which may be a sign that this medicine is not working properly. Signs of high blood sugar and high blood fats are listed in section 4 under “Signs of high and low blood sugar” and “Signs of high blood fats”.
If you notice any of the symptoms mentioned above and are described in more detail in section 4 of this leaflet, or if you are not sure, talk to your doctor straight away. Your doctor may need to change your treatment.
Autoimmune disease
In people who have or have had problems with the immune system (an autoimmune disease, including autoimmune liver disease), the symptoms may be aggravated by Myalepta. Talk to your doctor about what symptoms you should be aware of as they may mean that more tests need to be done.
Allergic reactions
During treatment with Myalepta, you may have an allergic reaction. Tell your doctor immediately if you get symptoms of an allergic reaction. Signs of an allergic reaction are described in section 4 under “Allergic reactions”.
Fertility
Myalepta may increase fertility in women with lipodystrophy (see section “Pregnancy, breastfeeding and fertility”).
How to stop using Myalepta
If you need to stop using Myalepta, your doctor will reduce the dose gradually over two weeks before stopping treatment completely. Your doctor will also ask you to follow a low-fat diet.
- It is important to reduce the dose by one pregnant woman for two weeks, as this can help prevent a sudden increase in blood fats (called triglycerides ).
- A sudden increase in the amount of triglycerides in your blood can cause pancreatitis. This can be prevented by gradually reducing dose one and following a low fat diet.
Do not stop using Myalepta unless your doctor tells you to.
Children and young people
Do not give this medicine to children under 2 years of age with generalized lipodystrophy or under 12 years of age with partial lipodystrophy. This is because it is not known how this drug affects children under these ages.
Other medicines and Myalepta
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Myalepta may affect the effectiveness of certain other medicines. Some other medicines may also affect the way this medicine works.
In particular, tell your doctor if you are taking any of the following medicines:
- cholesterol lowering statins (such as atorvastatin)
- blood pressure medication called calcium channel blocker
- theophylline used in lung problems such as asthma
- blood-thinning drugs (such as warfarin or fenprocumon)
- medicines for epilepsy or seizures (such as phenytoin )
- drugs that inhibit the immune system (such as cyclosporine)
- sleep or anti-anxiety drugs called benzodiazepines
If any of the above apply to you (or you are not sure), talk to your doctor before using Myalepta. Some medicines need to be monitored while you are using Myalepta, as the dose of one of these medicines may need to be changed.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not use Myalepta if you are pregnant or could become pregnant. This is because it is not known how metreleptin affects your unborn baby.
- Women who may become pregnant should use an effective method of contraception, including a non-hormonal method such as a condom, during treatment with Myalepta.
Talk to your doctor if you are breastfeeding. You and your doctor will decide if you should continue breastfeeding while taking this medicine.
It is not known if metreleptin is excreted in human milk.
Myalepta may increase fertility in women with lipodystrophy.
Driving and using machines
Myalepta has less effect on the ability to drive and use machines. You may feel dizzy or tired when using this medicine. If this happens, do not drive or use any tools or machines. Talk to your doctor if you are unsure.
How to use Myalepta
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Myalepta is an injection given once a day under the skin ( subcutaneous injection ). This medicine is intended for use in children 2 years of age and older, adolescents, and adults with generalized lipodystrophy. It is also intended for use in children 12 years of age and older, adolescents, and adults with partial lipodystrophy.
While using this medicine, you or your child will be monitored by your doctor who will decide what dose you or your child should use.
Your doctor may decide to inject you. Your doctor, nurse, or pharmacist will show you how to prepare and inject the medicine.
- Do not try to prepare or inject the medicine yourself unless you have been trained.
How much to inject
Your dose of Myalepta may change over time depending on how this medicine works for you. The Myalepta powder is dissolved by mixing it with water for injections to prepare the solution for injection. Read the “Instructions for Use” (section 7) for instructions on how to prepare the solution before injection.
Your doctor has prescribed the right dose for you as follows:
- If you weigh 40 kg or less:
- The starting dose is 0.06 mg (0.012 ml solution) per kg body weight.
- If you are a male patient and weigh more than 40 kg:
- The starting dose is 2.5 mg (0.5 ml solution).
- If you are a female patient and weigh more than 40 kg:
- The starting dose is 5 mg (1 ml solution).
Your doctor or pharmacist will tell you how many solutions to inject. If you are not sure how much to inject, talk to your doctor or pharmacist before injecting.
- Which syringe to use to inject this medicine depends on the dose you have been prescribed.
- The pharmacy staff gives you the right syringe for injection .
- See “Instructions for Use” for information on which syringe to use.
- To know how much medicine to inject (in ml), divide your dose (in mg) by 5.
- If you e.g. has been prescribed a 5 mg dose of Myalepta, divided 5 mg by 5, giving 1 ml. This is the amount of solution you need to inject with a 1 ml syringe .
- If your dose is 1.50 mg (0.30 ml solution) or less, use a 0.3 ml syringe .
- The 0.3 ml syringe shows the volume of injection in units instead of ml. See “Instructions for Use” (see section 7) for more information on how to read and use the different syringes.
- To know how much solution to inject (in units), divide your dose (in mg) by 5 and then multiply by 100.
If you need to inject 1 ml or more of Myalepta solution, your doctor may ask you to give one or two separate injections. This can make the injections more comfortable.
You must use a clean syringe and needle for both injections.
If you are not sure how much to inject, talk to your doctor or pharmacist before injecting.
When small doses/volumes are prescribed (for example for children), the vial will still be almost filled with medicine when dose one has been withdrawn. The rest of the solution should be discarded after use.
If you use more Myalepta than you should
If you have used too much Myalepta, talk to a doctor or go to a hospital straight away. Your doctor will monitor you for side effects.
If you forget to use Myalepta
- If you forget to inject a dose , inject it as soon as you remember.
- Take the normal dose the next day.
- Do not take a double dose to make up for a forgotten dose .
If you have injected less Myalepta than you were told to, talk to a doctor immediately. Your doctor will monitor you for side effects.
If you stop using Myalepta
Do not stop using Myalepta without talking to your doctor. Your doctor will decide if you should stop using this medicine.
If you need to stop using Myalepta, your doctor will reduce the dose gradually over two weeks. See section 2 “How to stop using Myalepta” for more information.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects with this medicine:
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention. If you are unable to contact your doctor, seek emergency medical attention.
- low blood sugar
- high blood sugar
- blood clot in a vein (deep vein thrombosis ) – pain, swelling, feeling hot and redness , usually in the lower leg or thigh
- fluid in the lungs – difficulty breathing or coughing
- drowsiness or confusion
Allergic reactions
Talk to a doctor immediately if you notice an allergic reaction, eg:
- breathing problems
- swelling and redness of the skin, hives
- swelling of the face, lips, tongue or throat
- abdominal pain, nausea and vomiting
- fainting or dizziness
- severe abdominal pain
- very fast pulse
Pancreatitis
Talk to a doctor immediately if you notice signs of pancreatitis, for example:
- sudden severe abdominal pain
- nausea or vomiting
- diarrhea
Other side effects are
Talk to your doctor if you notice any of the following side effects.
Very common (may affect more than 1 user in 10):
- weight loss
Common (may affect up to 1 in 10 people):
- loss of appetite
- headache
- hair loss
- unusually heavy or prolonged menstrual bleeding
- fatigue
- bruising, redness , itching or hives at the injection site
- The body produces antibodies against metreleptin, which may increase the risk of serious or severe infections . You may notice that you get a fever along with increased fatigue
Has been reported (occurs in an unknown number of users):
- influenza
- respiratory tract infection
- diabetes
- increased appetite or excessive eating
- faster heart rate
- cough
- respiratory distress
- muscle aches
- joint pain
- swollen hands and feet
- increased adipose tissue
- swelling or bleeding under the skin at the injection site
- feeling of general discomfort, discomfort or pain (feeling sick)
- increased blood fats ( triglycerides )
- increase in HbA 1c in the blood, seen in tests
- weight gain
- swelling or bleeding under the skin
- high blood sugar
- fever
- overindulge
- shaking.
Tell your doctor if you notice any of the side effects listed above.
Signs of high and low blood sugar
Symptoms of low blood sugar are:
- dizziness
- increased drowsiness or confusion
- clumsiness and losing things
- increased appetite
- increased sweating
- increased irritation or nervousness
If you notice any of the above symptoms, or you are not sure, talk to your doctor. Your doctor may need to change your treatment.
Symptoms of high blood sugar are:
- strong thirst or hunger
- increased need for urination
- increased sleepiness
- nausea or vomiting
- dimsyn
- pain in chest or back
- shortness of breath
Signs of high blood fats
Symptoms of high blood fats are:
- chest pain
- pain below the ribs such as heartburn or indigestion
- nausea or vomiting
Tell your doctor if you notice any of the side effects listed above.
How to store Myalepta
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 vial and carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2-8 ° C). Keep the vial in the outer carton. Sensitive to light. After reconstitution, the solution must be administered immediately and must not be saved for later use. Discard any unused medicine.
Do not use this medicine if the solution is not clear, if it is colored or if it contains particles or lumps.
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.
Contents of the pack and other information
Content declaration
- The active substance is metreleptin.
- One vial contains 3 mg metreleptin. After reconstitution of the contents of the vial with 0.6 ml of water for injections, 1 ml contains 5 mg of metreleptin.
- The other ingredients are: glycine , sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment ).
What the medicine looks like and contents of the pack
Myalepta is supplied as a powder for solution for injection. It is a white powder supplied in a glass vial with a rubber stopper and an aluminum seal with a red plastic snap cap.
Myalepta is available in packs containing 1 or 30 vials.
Not all pack sizes may be marketed.
Your doctor, nurse, or pharmacist should give you suitable syringes and needles, syringes, and water for injections separately so that you can prepare and inject Myalepta. They give you a container for stinging and cutting waste where you should put used vials, syringes, and needles.
Marketing Authorisation Holder
Amryt Pharmaceuticals DAC
45 Mespil Road Dublin 4
Ireland
medinfo@amrytpharma.com
Manufacturer
Eurofins PHAST GmbH
Cardinal Wendel Straße
16 66424 Homburg
Germany
This medicine has been authorized according to the rules of “authorization in exceptional cases”. This means that it has not been possible to obtain complete information about this medicine as the disease is rare.
Every year, the European Medicines Agency reviews any new information and updates this leaflet when necessary.