Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin. The consequences are not well characterized but could include inhibition of endogenous leptin action and/or loss of metreleptin efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of metreleptin efficacy during treatment. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with metreleptin. Carefully consider the benefits and risks of treatment with metreleptin in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. Metreleptin is available only through a restricted program called the Myalept(TM) REMS Program .
Metreleptin injection is used together with a proper diet as replacement therapy to treat problems caused by leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
This medicine is only available under a restricted distribution program called Myalept™ REMS program.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metreleptin injection in children.
Although appropriate studies on the relationship of age to the effects of metreleptin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving metreleptin injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional may give you or your child this medicine. You or your health caregiver may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.
Each package of metreleptin contains a Medication Guide and patient instructions. Read the instructions carefully and make sure you understand:
It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, or upper arm). If you have questions about this, contact a member of your health care team.
The powder medicine in the vial should be white and not discolored. Do not shake or use the mixed medicine if it is cloudy, discolored, or has large particles in it.
This medicine can be mixed with bacteriostatic water for injection (BWFI) or sterile water for injection (WFI). Ask your doctor which liquid should be used and mixed with your medicine.
This medicine should be given at the same time each day, taken with or without food.
Do not mix this medicine and insulin in the same syringe or vial. Also, do not inject this medicine and insulin at the same injection site.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Unused vials: Store the unused vials in the refrigerator. Protect from direct light. Do not freeze.
Mixed medicine with bacteriostatic water for injection (BWFI): This mixture can be used for more than one dose for up to 3 days when stored in the refrigerator and away from direct light. Throw away any unused medicine after 3 days.
Mixed medicine with sterile water for injection (WFI): This mixture should be used right away and should not be saved for later use.
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Some patients who use this medicine may make antibodies in their blood which may reduce how well this medicine or the leptin in the body works. This may lead to side effects such as infection, diabetes, or an increase in the amount of fat in the blood. Tell your doctor right away if you or your child have these side effects while receiving this medicine.
Using this medicine may increase your risk of getting lymphoma (cancer of the lymph system). Talk to your doctor if you or your child have concerns about this risk.
Hypoglycemia (low blood sugar) may occur when this medicine is used together with insulin or a diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.
Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.
If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur . Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.
Do not stop using this medicine suddenly without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.
This medicine mixed with bacteriostatic water for injection (BWFI) contains benzyl alcohol, which may cause serious reactions in premature or low-birth-weight infants. Sterile water for injection (WFI) is recommended for use in newborn and premature infants. Discuss this with your doctor if you are concerned.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.