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Generic Name: somatropin (rdna origin - refrigerated) (SOE-ma-TROE-pin)
Brand Name: Examples include Nutropin and Tev-Tropin
Tev-Tropin is used for:
Treating certain children or adults when the body does not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.
Tev-Tropin is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.
Do NOT use Tev-Tropin if:
- you are allergic to any ingredient in Tev-Tropin
- you have active or recurring cancer or brain tumor, or you currently receive treatment for cancer
- you have severe breathing problems (eg, respiratory failure) or serious illness caused by complications from surgery or injury
- you have a certain type of eye problem caused by diabetes (diabetic retinopathy)
- the patient is a child who has Prader-Willi syndrome and is severely overweight or has severe breathing problems (eg, respiratory infection, history of airway blockage or sleep apnea)
- the patient is a child who has epiphyseal closure (bone growth is complete)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tev-Tropin:
Some medical conditions may interact with Tev-Tropin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (especially benzyl alcohol or m-cresol)
- if you have a history of kidney or liver problems, lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, ear or hearing problems (eg, repeated ear infections), pancreas problems, or endocrine problems (eg, pituitary or adrenal gland problems)
- if you have a history of diabetes or high blood sugar levels, or if a member of your family has had diabetes
- if you have a history of leukemia, other types of cancer, or any unusual growths or tumors (especially in the brain)
- if you have curvature of the spine (scoliosis), Prader-Willi syndrome, or a certain eye problem called papilledema (swelling of the area around your optic nerve)
- if you are very overweight or have had recent major surgery or injury
Some MEDICINES MAY INTERACT with Tev-Tropin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone) or estrogens because they may decrease Tev-Tropin's effectiveness
- Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Tev-Tropin
- Insulin or other medicines for diabetes because their effectiveness may be decreased by Tev-Tropin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tev-Tropin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tev-Tropin:
Use Tev-Tropin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Tev-Tropin. Talk to your pharmacist if you have questions about this information.
- Tev-Tropin is given as an injection under the skin. Before you use Tev-Tropin, a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Tev-Tropin or giving injections.
- If you are using Tev-Tropin at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
- Do NOT shake Tev-Tropin. Swirl gently to mix.
- Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Tev-Tropin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Tev-Tropin.
Important safety information:
- Severe and sometimes fatal lung and breathing problems have occurred with use of Tev-Tropin in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, lung or airway infection, history of airway blockage or sleep apnea). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Tev-Tropin. They should be monitored for signs of lung or airway infection. They should also have effective weight control. Contact the doctor right away if the patient develops irregular breathing during sleep, new or increased snoring, or symptoms of lung or airway infection (eg, fever, coughing, sore throat, shortness of breath, chest pain or discomfort).
- An increased risk of a second cancer has been seen in patients that had certain types of cancer as a child and received Tev-Tropin to treat the lack of growth hormone. Discuss any questions or concerns with your doctor.
- Rarely, children using Tev-Tropin have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.
- Rarely, increased pressure in the head has been reported in patients using somatropin. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Symptoms usually occurred within the first 8 weeks after the start of treatment. The symptoms have gone away after the dose was lowered or treatment was stopped. Discuss any questions or concerns with your doctor. Contact your doctor right away if you develop symptoms such as vision changes or severe headache, nausea, or vomiting.
- Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Tev-Tropin. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.
- Tev-Tropin may contain glycerin, or the preservatives benzyl alcohol or metacresol (m-cresol). Tell your doctor if you have ever had an allergic reaction to any of these ingredients.
- Tev-Tropin may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Tev-Tropin may affect your blood sugar levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.
- Lab tests, including blood sugar levels, eye exams, and thyroid function, may be performed while you use Tev-Tropin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Tev-Tropin with caution in the ELDERLY; they may be more sensitive its effects.
- Tev-Tropin may have benzyl alcohol in it. Do not use medicines that contain benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tev-Tropin while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Tev-Tropin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Tev-Tropin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Fatigue; headache; increased appetite; mild arm or leg pain or stiffness; mild pain, redness, itching, swelling, bruising, or bleeding at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain; stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; difficult or painful urination; ear pain, discharge, or discomfort; fever, chills, or persistent sore throat; hearing problems; hip or knee pain; limp; mental or mood changes (eg, aggressiveness, depression); nausea or vomiting; new growth on the skin; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include swelling of the hands, ankles, or feet; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).Proper storage of Tev-Tropin:
Before mixing, store Tev-Tropin in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Tev-Tropin past the expiration date on the product label.
After mixing, store Tev-Tropin as directed in the extra patient leaflet or by your health care provider.
Contact your pharmacist if you have any questions about the proper storage of Tev-Tropin. Keep Tev-Tropin, as well as needles and syringes, out of the reach of children and away from pets.
- If you have any questions about Tev-Tropin, please talk with your doctor, pharmacist, or other health care provider.
- Tev-Tropin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Tev-Tropin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tev-Tropin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tev-Tropin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Tev-Tropin.