Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - myalepta

Document Subject

Generated Narrative: MedicinalProductDefinition mp1938b3b2db3127440139b7029093a2b8

identifier: http://ema.europa.eu/identifier/EU/1/18/1276/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Myalepta 3 mg powder for solution for injection.

type: Full name

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part: nan

type: Invented name part

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type: Scientific name part

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1938b3b2db3127440139b7029093a2b8

identifier: http://ema.europa.eu/identifier/EU/1/18/1276/003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - myalepta

Attesters

What is in this leaflet

1. What Myalepta is and what it is used for
2. What you need to know before you use Myalepta
3. How to use Myalepta
4. Possible side effects
5. How to store Myalepta
6. Contents of the pack and other information

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 the complications of not having enough leptin in patients with lipodystrophy.

It is used in adults, adolescents and children 2 years or over:

• who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue)

It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over:

• who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
• or partial lipodystrophy has been caused by your body s response to something such as a viral illness (also called acquired lipodystrophy)

How Myalepta works Natural leptin is produced by fatty tissue and has many functions in the body including:

• controlling how hungry you feel and your energy levels
• helping the insulin in your body manage sugar levels. Metreleptin works by copying the effects of leptin. This improves the ability of the body to control energy levels.

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 precautions Talk to your doctor, pharmacist or nurse before using Myalepta if:

• you are pregnant
• you have ever had a type of cancer called lymphoma
• you have ever had problems with your blood (such as a low blood count)
• you have ever had inflammation of an organ called the pancreas ( pancreatitis )
• you have or ever have had problems with your immune system (autoimmune disease including autoimmune-related liver problems)

Lymphoma

People with lipodystrophy can get a type of blood cancer called lymphoma, whether or not they are using Myalepta. However, you may be at higher risk of getting a lymphoma when using the medicinal product. Your doctor will decide if you should use Myalepta and will monitor you during treatment.

Serious and severe infections

While being treated with Myalepta, your body might produce antibodies which may increase the risk of developing serious or severe infections. Tell your doctor straight-away if you develop a high temperature, accompanied by increasing tiredness (see section 4).

Low blood sugar with insulin or other anti-diabetic medicines

If you are using a medicine such as insulin or other medicines to treat diabetes, your doctor will closely monitor your blood sugar. Your doctor will change your dose of insulin or other medicines if needed. This is to prevent your blood sugar from getting too low ( hypo-glycaemia ). For signs of low blood sugar levels, see section 4 under Signs of high and low blood sugar'.

High blood sugar and fat levels

You may have higher amounts of sugar ( hyper-glycaemia ) or fat ( hyper-triglyceridaemia ) in your blood while on Myalepta, which may be a sign that this medicine is not working as well as it should. Signs of high blood sugar levels and high fat levels are listed in section 4 under Signs of high and low blood sugar and Signs of high fat . If you notice any of the symptoms referred to above and described further in section 4 of this leaflet, or you are not sure, talk to your doctor straight away. Your doctor might need to change your treatment.

Autoimmune disease

People who have or have had problems with their immune system (autoimmune disease, including autoimmune-related liver problems) may have worsening of their symptoms with Myalepta. Talk to your healthcare provider about what symptoms you should watch for that would warrant further testing.

Allergic reactions

While being treated with Myalepta, you may get an allergic reaction. Tell your doctor straight-away if you have any symptoms of an allergic reaction. Signs of an allergic reaction can be seen in section 4 under Allergic reactions .

Fertility

Myalepta might increase fertility in women with lipodystrophy (see section Pregnancy, breast-feeding and fertility ).

Myalepta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium free .

Children and adolescents Do not give this medicine to children below the age of 2 years with generalised lipodystrophy, or below the age of 12 years with partial lipodystrophy. This is because it is not known how this medicine will affect children under these ages.

Other medicines and Myalepta Tell your doctor if you are using, have recently used or might use any other medicines. Myalepta can affect the way some other medicines work. Also some other medicines can affect the way this medicine works. In particular, tell your doctor if you are taking any of the following medicines:

• hormonal contraceptives as Myalepta may reduce how well they work at preventing pregnancy
• theophylline used in lung problems such as asthma
• blood-thinning medicines (such as warfarin or phenprocoumon)
• medicines which suppress the immune system (such as cyclosporine)
• anti-diabetic medicines (such as insulin or insulin secretagogues), see section 2 Low blood sugar with insulin or other anti-diabetic medicines

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 since the dose of these medicines might need to be changed.

Pregnancy, breast-feeding 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.

You should not use Myalepta if you are pregnant or might become pregnant. This is because it is not known how Myalepta will affect your unborn baby. Women who could get pregnant should use effective contraception, including non-hormonal methods such as condoms, while using Myalepta. Discuss appropriate contraceptive methods with your doctor as Myalepta may reduce how well hormonal contraceptives work at preventing pregnancy.

It is not known if Myalepta will pass into breast milk. Talk to your doctor if you are breast-feeding or plan to do so. You and your doctor will decide whether or not to continue breast-feeding while using this medicine, considering the benefit of breast-feeding the baby and the benefit of Myalepta to the mother.

Myalepta might increase fertility in women with lipodystrophy.

Driving and using machines Myalepta has minor influence on the ability to drive and use machines. You might 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 not sure.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Myalepta is an injection once a day under the skin ( subcutaneous injection ). This medicine is for use in children aged 2 years and above, adolescents and adults with generalised lipodystrophy; it is also for use in children aged 12 years and above, adolescents and adults with partial lipodystrophy.
While using this medicine, you or your child will be monitored by your doctor, who will decide the dose you or your child should use.

Your doctor may decide that you inject the medicine yourself. Your doctor, nurse or pharmacist will show you how to prepare and inject this medicine.

• Do not try to prepare the medicine or inject yourself if you have not 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 make the solution for injecting. Read the Instructions for Use for how to make the solution before injecting. Your doctor will have prescribed the correct dose for you, based on the following:

• If you weigh 40 kg or less:

A starting dose is 0.06 mg (0.012 mL of solution) for each kilogram of body weight.

• If you are male and weigh more than 40 kg:

A starting dose is 2.5 mg (0.5 mL of solution).

• If you are female and weigh more than 40 kg:

A starting dose is 5 mg (1 mL of solution). Your doctor or pharmacist will tell you how much of the solution to inject. If you are not sure how much of the solution to inject, talk to your doctor or pharmacist before injecting.

• The syringe you need to use to inject this medicine depends on the dose prescribed for you. * Your pharmacist will give you the correct syringe for injecting. * See the Instructions for Use to find out which syringe to use.
• To know how much medicine to inject (in mL), you divide your dose (in mg) by 5.* For example, if you have been prescribed a 5 mg dose of Myalepta, 5 mg divided by 5 gives you 1 mL which is the amount you need to inject of the solution, using a 1 mL syringe.
• If your dose is 1.50 mg (0.30 mL of solution) or less, you will need to use a 0.3 mL syringe. * The 0.3 mL syringe will show the injection amount in Unit instead of mL . See the Instructions for Use (section 7) for more information on reading and using the different syringes. * To know how much solution to inject (in Units), divide your dose (in mg) by 5, and then times it by 100. If you need to inject 1 mL or more of Myalepta solution, your doctor might tell you to give the dose as two separate injections. This can help make the injections more comfortable. You must use a clean syringe and needle for both injections. If you are not sure how much of the solution to inject, talk to your doctor or pharmacist before injecting. When small doses/volumes are prescribed (e.g. in children), the vials will remain almost completely filled with product after withdrawal of the required dose. Remaining solution should be discarded after use.

If you use more Myalepta than you should If you use more Myalepta than you should, talk to your 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.
• Then have your normal dose the next day.
• Do not use a double dose to make up for a forgotten dose. If you have injected less Myalepta than you should, talk to your doctor straight away. 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 gradually reduce the dose over two weeks before stopping it altogether. Your doctor will also ask you to follow a reduced fat diet.

• It is important to gradually reduce the dose over two weeks because this can help prevent a sudden increase in the levels of fat (called triglycerides ) in your blood.
• A sudden increase in the amount of triglyceride in your blood can make your pancreas inflamed ( pancreatitis ). Gradually reducing your dose, and following a reduced fat diet may help to prevent this. You should not stop using Myalepta unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects with this medicine:

Serious side effects Tell your doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment. If you cannot contact your doctor, you should seek emergency medical help:

• low blood sugar (glucose), see section Signs of high and low blood sugar below.
• increased blood sugar (glucose)
• blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh
• fluid in your lungs - difficulty breathing or cough
• feeling sleepy or confused

Allergic reactions
Talk to a doctor straight away if you notice any severe allergic reactions, including:

• breathing problems
• swelling and reddening of the skin, hives
• swelling of your face, lips, tongue or throat
• stomach pain, feeling sick (nausea) and being sick (vomiting)
• fainting or feeling dizzy
• severe pain in your stomach (abdomen)
• very fast heartbeat

Inflamed pancreas ( pancreatitis ): Talk to a doctor straight away if you notice any signs of an inflamed pancreas, including:

• sudden severe pain in your stomach (abdomen)
• feeling sick (nausea) or being sick (vomiting)
• diarrhoea

Other side effects Tell your doctor if you notice any of the following side effects.

Very common (may affect more than 1 in 10 people):

• weight loss

Common (may affect up to 1 in 10 people):

• loss of interest in food
• headache
• hair loss
• unusually heavy or long menstrual bleeding
• feeling tired
• bruising, reddening, itching or hives where the injection is given
• your body producing antibodies to metreleptin which may increase the risk of developing serious or severe infections. You may notice you develop a high temperature, accompanied by increasing tiredness

Not known (frequency cannot be estimated from the available data):

• flu
• chest infection
• diabetes
• a higher than normal desire for food or excessive eating
• a faster than normal heart rate
• cough
• breathlessness
• muscle pain ( myalgia )
• joint pain
• swelling in your hands and feet
• increase in fatty tissue
• swelling or bleeding under the skin, where you injected
• pain at the injection site
• itchiness at the injection site
• a feeling of general discomfort, uneasiness or pain ( malaise )
• increased fat in the blood ( triglycerides ) (see section Signs of high fat below)
• an increase in HbA1c in your blood, shown in tests
• weight gain
• swelling or bleeding under the skin ( haemorrhage )
• high blood sugar levels (see section Signs of high and low blood sugar below). Tell your doctor if you notice any of the above side effects.

Signs of high and low blood sugar Symptoms of low blood sugar levels include:

• feeling dizzy
• feeling more sleepy or confused
• being clumsy and dropping things
• feeling more hungry than normal
• sweating more than normal
• feeling more irritable or more nervous If you notice any of the symptoms above, or you are not sure, talk to your doctor straight away. Your doctor might need to change your treatment. Symptoms of high blood sugar levels include:
• feeling very thirsty or hungry
• going to the toilet to pass urine more often
• feeling more sleepy
• feeling sick or being sick
• blurred vision
• pain in the chest or back
• feeling out of breath

Signs of high fat Symptoms of high fat levels include:

• pain in the chest
• pain below the ribs like heartburn or indigestion
• feeling sick or being sick

Tell your doctor if you notice any of the above side effects.

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 via the national reporting system 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 vial and carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C-8 C). Keep the vial in the outer carton in order to protect from light. After reconstitution, the solution must be administered immediately and cannot be stored for later use. Dispose of any unused medicine.

Do not use this medicine if the solution is not clear, is coloured or has bits or lumps in it.

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.

What Myalepta contains

• The active substance is metreleptin. Each vial contains 3 milligrams of metreleptin. After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
• The other ingredients are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment).

What Myalepta looks like and contents of the pack

Myalepta is presented as a powder for solution for injection (powder for injection). It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a red plastic flip-off cap.

Myalepta is available in packs containing 1 or 30 vials.

Not all pack sizes may be marketed in your country.

Your doctor, nurse or pharmacist should provide you separately with the appropriate syringes and needles, wipes and water for injections to enable you to prepare and inject Myalepta. They will provide a sharps disposal container for you to put your used vials, syringes and needles in.

Marketing Authorisation Holder Amryt Pharmaceuticals DAC 45 Mespil Road Dublin 4 Ireland
medinfo@amrytpharma.com

Manufacturer Eurofins PHAST GmbH Kardinal-Wendel-Stra e 66424 Homburg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 Lietuva ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com

ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Te .: +359 888 918 pv.global@exceedorphan.com

Luxembourg/Luxemburg Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 esk republika ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +420 724 321 pv.global@exceedorphan.com
Magyarorsz g ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +36 20 399 4pv.global@exceedorphan.com

Danmark Chiesi Pharma AB
Tlf: + 46 8 753 35 Malta Amryt Pharmaceuticals DAC Tel: +44 1604 549medinfo@amrytpharma.com

Deutschland Chiesi GmbH
Tel: + 49 40 89724-0

Nederland Chiesi Pharmaceuticals B.V.
Tel: + 31 88 501 64 Eesti ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com
Norge Chiesi Pharma AB
Tlf: + 46 8 753 35
Amryt Pharmaceuticals DAC T : +800 44 474T : +44 1604 549medinfo@amrytpharma.com

sterreich Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U.
Tel: + 34 93 494 8Polska ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +48 502 188 pv.global@exceedorphan.com

France Chiesi S.A.S.
T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Hrvatska ExCEEd Orphan Distribution d.o.o. Savska cesta 32, Zagreb, 100 Croatia
Tel: +385 99 320 0pv.global@exceedorphan.com Rom nia ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +40 744 366 pv.global@exceedorphan.com

Ireland Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Slovenija ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +386 30 210 pv.global@exceedorphan.comy

sland Chiesi Pharma AB
S mi: +46 8 753 35 Slovensk republika ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +420 608 076 pv.global@exceedorphan.com

Italia Chiesi Italia S.p.A.
Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB
Puh/Tel: +46 8 753 35
Amryt Pharmaceuticals DAC T : +800 44 474T : +44 1604 549medinfo@amrytpharma.com

Sverige Chiesi Pharma AB
Tel: +46 8 753 35 Latvija ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com

United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2This leaflet was last revised in

This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: