Myalept

Myalept injection is administered to use as a treatment for complications of leptin deficiency in people with lipodystrophy.

Available under restriction, Metreleptin, with the brand name Myalept, can only be obtained under the Myalept REMS program.

If you are about to start Myalept, speak with your doctor about what you need to know. The risks and benefits the medicine offer must be weighed.

For Myalept, you and your doctor must consider the following:

Allergies. If you have any unusual reaction to any medicine, including Myalept, be sure to tell your doctor about it. Additionally, disclose other types of allergies - foods, preservatives, animals, or dyes, if there are any. Read the package ingredients carefully and make sure you are not allergic to any of its ingredients.

Pediatric. Studies show that administering metreleptin injections to children is possible when needed.

Geriatric. While there are no appropriate studies that state age-related problems as an effect of metreleptin injections to the elderly, no reports of incidents are documented to date. Nevertheless, older people tend to have other diseases that concern the heart, kidney, or liver, which will require caution.

Pregnancy. While there are no adequate studies done in pregnant women, animal studies show an adverse effect.

Breastfeeding. No adequate studies were done determine the effect of the drug to infant during breastfeeding. When breastfeeding, weighing the benefits against the medication’s potential risks is important.

Drug Interactions. Certain medicines have adverse effects when used together. Make sure to inform your doctor about other drugs you are taking, so that alterations and precautions will be made if necessary.

Before taking Myalept, talk to your doctor about possible interactions if you are taking one or more of the following:

• Chlorpropamide
• Acetohexamide
• Gliclazide
• Glipizide
• Glimepiride
• Glyburide
• Gliquidone
• Insulin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Bovine
• Insulin Glulisine
• Insulin Detemir
• Insulin Lispro, Recombinant
• Nateglinide Repaglinide

Moreover, if you are smoking or drinking alcohol, discuss it first with your doctor.

Medical problems. Certain medical problems may affect the effectiveness of metreleptin. If you have autoimmune disorders, blood or bone marrow problems, make sure to discuss it with your doctor as taking the medicine may increase the risk of having lymphoma in special cases.

Patients with obesity not caused by congenital leptin deficiency, lipodystrophy and another metabolic disease that are not congenital, should refrain from taking the medicine.

To use Myalept properly, you must follow all instructions given by your doctor. A trained health practitioner may help you administer the medicine or teach you how to give the medicine at home. Metreleptin is administered by injecting it under the skin.

Myalept packaging has a medication guide and patient instructions. It is important to read the instructions carefully.

Make sure you understand how it is prepared, how it is injected, and how the used syringes, needles, and vials are disposed of. Using a different site on the body for each dose is advised.

Take note of the following:

• Metreleptin comes in powder form. The powder should be white and not discolored.
• Do not use a cloudy or discolored mixture, or if it has large particles in it.
• The powder is mixed with either BWFI (bacteriostatic water for injection) or WFI (sterile water for injection).
• The medicine should be administered at the same time each day.
• Never mix metreleptin with insulin.
• Do not inject metreleptin and insulin at the same site of injection.

Dosing:

The dose of metreleptin depends on the patient's age, weight, and symptoms, as well as the strength of the medicine. Do not change the dosage the doctor indicated unless he or she told you otherwise.

The number of doses and the number of hours between doses generally depend on the reason why you are taking metreleptin.

Generally, dosage will be as follows:

• For congenital/ acquired generalized lipodystrophy, the dosage is usually based on body weight.
• Children and adults with over 40 kilograms of weight may start at 5 milligrams per day for a female, and 2.5 milligrams per day for a male.
• Children and adults weighing less than 40 kilograms usually have a starting dose of 0.06 mg per kilogram of body weight. Dosages will be adjusted by the doctor as needed.

Missed dose:

Take the missed dose as soon as possible. In case, it is almost time for the next dose, skip the missed one and follow your regular dosing schedule. Never take double doses.

Storage:

Store unused vials in the refrigerator, away from children’s reach. Keep the medicine away from direct light and protect from freezing.

If the medicine is mixed with BWFI, you can store the mixture for three days in the refrigerator. In case it is mixed with WFI, use the mixture right away and throw any excess mixture.

Before using Myalept, there are some precautions you must take. Regular visits to the doctor are important to determine if the medicine is properly working. To check unwanted side effects, blood tests may be required.

In some people, the use of Myalept promotes the production of antibodies, which may hinder the medicine’s effects or may result in side effects like diabetes, infection, or an increased amount of fat in the blood.

If you are experiencing these side effects, contact your doctor immediately. Additionally, the risk of lymphoma is increased with metreleptin intake.

Low blood sugar or hypoglycemia may occur when metreleptin is used with a diabetes medicine or insulin. The symptoms of hypoglycemia should be treated immediately before they lead to passing out.

Therefore, it is important that you know what symptoms of hypoglycemia you usually have.

These symptoms may include behavior change (like being drunk), anxiety, cold sweats, blurred vision, depression, confusion, dizziness, thinking difficulty, excessive hunger, drowsiness, headache, fast heartbeat, irritability, slurred speech, and shakiness among others.

Glucose tablets may be taken to relieve these symptoms. If symptoms persist, go to the ER as soon as possible.

Do not stop metreleptin intake abruptly. Discuss it first with your doctor, since it is usually needed to be taken in decreasing doses before stopping it completely.

For newborn and premature infants, sterile water for injection is recommended for mixing, as bacteriostatic water for injection has benzyl alcohol that may cause potentially hazardous side effects.

Not all people using Myalept may suffer from these side effects, but if they do, immediate medical attention may be needed. 

Contact your doctor as soon as possible if you encounter any of the following:

More common side effects include:

• blurred vision
• anxiety
• body aches
• burning
• itching
• numbness
• the feeling of “pins and needles”
• cold sweats
• chills or fevers
• confusion
• dizziness
• headache
• fast heartbeat
• nausea
• nervousness
• increased hunger
• unusual tiredness

Less common side effects include:

• stomach aches,
• bloating,
• pains in the side that may radiate to the back,
• vomiting.

While some of these side effects usually go away without needing medical attention, it is advisable to inform your doctor about them so they can tell you what to do to prevent them.

You may report the side effects of metreleptin to the FDA at 1-800-FDA-1088.