Skytrofa

lonapegsomatropin-tcgdMed Info

This medication is used to treat growth failure (also known as dwarfism) due to a lack of growth hormone. Growth hormone is normally produced in the brain by a certain gland (pituitary gland) and has various effects on development in the body. A lack of growth hormone in children results in slowed growth and short height for the child's age. Lonapegsomatropin works by providing more growth hormone, which may help the long bones (such as the arms and legs) grow longer.

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30 Cartridges, 3 mg

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About Skytrofa

Overview

This medication is used to treat growth failure (also known as dwarfism) due to a lack of growth hormone. Growth hormone is normally produced in the brain by a certain gland (pituitary gland) and has various effects on development in the body. A lack of growth hormone in children results in slowed growth and short height for the child's age. Lonapegsomatropin works by providing more growth hormone, which may help the long bones (such as the arms and legs) grow longer.

How to use

Read the manufacturer's Instructions for Use provided by your pharmacist before you start using lonapegsomatropin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Read and learn all preparation and usage instructions from the manufacturer and your health care professional. This medication is injected with a device made to help you use it properly. Do not share your device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

If your medication (cartridge) has been stored in the refrigerator, take it out of the refrigerator and bring it to room temperature for 15 minutes before use. Do not warm it up in any other way such as by heating in the microwave or placing in hot water. After mixing this medication as directed, check this product visually for particles or discoloration. If either is present, do not use the liquid.

This medication is given by injection under the skin of the stomach (abdomen), thighs, or buttocks as directed by your doctor, usually once weekly. Change the injection site each time to lessen injury under the skin.

The dosage is based on your medical condition, weight, and response to treatment.

Side effects

Nausea, vomiting, diarrhea, abdominal pain, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including development of a limp, hip/knee pain, numbness/tingling, increased thirst/frequent urination, swelling hands/ankles/feet, nausea/vomiting that doesn't stop, severe stomach/abdominal pain that doesn't stop, signs of bleeding (such as nosebleeds, small red or purple spots on the skin), symptoms of thyroid problems (such as cold intolerance, unexplained increased weight).

Get medical help right away if you have any very serious side effects, including seizure.

Lonapegsomatropin may increase your risk of getting a new tumor or cancer. Children who have had brain/head radiation treatment for cancer should be monitored for new tumors/cancers. Tell your doctor right away if you or a caregiver notice symptoms such as unusual changes in behavior, vision problems/changes, severe headache, changes in skin color, or change in the appearance or size of a mole. Talk with your doctor for details and to discuss the risks and benefits of this medication.

Rare (possibly fatal) lung/breathing problems may occur in children with Prader-Willi syndrome while using this medication. The risk is higher in children who are obese, male, or who have lung/breathing problems (such as sleep apnea, lung infections, lung disease). Tell the doctor right away if you notice signs of breathing problems or lung infection such as heavy snoring, interrupted breathing during sleep, fever, cough, or trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Warnings & Precautions

See also Side Effects section.

Before using lonapegsomatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of adrenal gland problems, eye problems (such as diabetic retinopathy), recent major surgery/injury, diabetes or family history of diabetes, obesity, kidney disease, cancer (especially of the head/neck), thyroid problems, a certain back problem (scoliosis), Prader-Willi syndrome.

If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Storage

Store the cartridges in the refrigerator or at room temperature. The cartridges may be put back in the refrigerator if they have been taken out. After first removal from the refrigerator, write the date on the outer carton and use the medication within 6 months. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Missed Doses:

If you miss a dose, use it as soon as you remember if it is not more than 2 days after the missed dose. If it is more than 2 days after the regular scheduled dose, skip the missed dose. Use your next dose on the regular scheduled day. Do not double the dose to catch up. If you decide to change the regular scheduled day, make sure to wait at least 5 days between the last dose and the new dosing day.

To avoid missed doses, this medication can be used 2 days before or 2 days after the scheduled dosing day.

Notes:

Do not share this medication with others.

Lab and/or medical tests (such as eye exam, thyroid function, blood sugar, parathyroid hormone, cortisol level) may be done while you are using this medication. Keep all medical and lab appointments.

Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. 

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