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Generic Name: somatropin (rdna origin - nonrefrigerated) (SOE-ma-TROE-pin)
Brand Name: Saizen
Saizen 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.
Saizen is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.
Do NOT use Saizen if:
- you are allergic to any ingredient in Saizen or in the diluent
- 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 a serious illness caused by complications from a 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 Saizen:
Some medical conditions may interact with Saizen. 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 (including benzyl alcohol)
- if you have a history of lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, pancreas problems, liver or kidney problems, or endocrine problems (eg, pituitary or adrenal gland problems)
- if you have a history of diabetes, high blood sugar levels, Turner syndrome, or if a member of your family has had diabetes
- if you have a history of leukemia, other types of cancer (eg, skin cancer), or any unusual growths or tumors (especially in the brain)
- if you have curvature of the spine (scoliosis), carpal tunnel syndrome, 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 a recent major surgery or injury
Some MEDICINES MAY INTERACT with Saizen. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Estrogens because they may decrease Saizen's effectiveness
- Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Saizen
- Corticosteroids (eg, cortisone, prednisone) or insulin or other medicines for diabetes because their effectiveness may be decreased by Saizen
This may not be a complete list of all interactions that may occur. Ask your health care provider if Saizen 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 Saizen:
Use Saizen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Saizen is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Saizen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Saizen should be clear and colorless. Do not use Saizen if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
- Do not shake Saizen. Swirl the vial gently to mix it.
- Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
- Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
- Keep this product, as well as syringes and needles, out of the reach of children and 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 Saizen, 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 Saizen.
Important safety information:
- Do NOT use more than the recommended dose or change your dose without checking with your doctor.
- Severe and sometimes fatal lung and breathing problems have occurred with the use of somatropin in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, airway blockage, sleep apnea, lung or airway infection). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Saizen. They should be monitored for signs of lung or airway infection. They should also have effective weight control. Contact the doctor at once 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).
- Rarely, increased pressure in the head has been reported in patients using somatropin. The risk may be greater in patients with chronic kidney problems, 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 use Saizen. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop severe stomach or back pain.
- An increased risk of a second cancer has been seen in patients that had certain types of cancer as a child and received Saizen to treat the lack of growth hormone. Discuss any questions or concerns with your doctor.
- Rarely, children using Saizen 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.
- Saizen may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Saizen may affect your blood sugar levels. Check your blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including blood sugar levels, blood electrolytes, thyroid function, and eye exams, may be performed while you use Saizen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Saizen with caution in the ELDERLY; they may be more sensitive to its effects. Safety and effectiveness of Saizen in patients older than 65 years old have not been confirmed.
- Saizen may have benzyl alcohol in it. Do not use it 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 Saizen 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 Saizen, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Saizen:
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:
Headache; mild pain, numbness, redness, or swelling at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; breast enlargement; burning, numbness, or tingling; change in appearance or size of a mole; chest pain; depression; ear pain, discharge, or discomfort; fast heartbeat; fever, chills, or persistent cough or sore throat; hip or knee pain; limp; new growth on the skin; one-sided weakness; severe or persistent stomach or back pain, nausea, or vomiting; 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; confusion; unusual drowsiness); 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 ankles, feet, or hands; 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 Saizen:
Store new (unopened) vials at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom.
If you mix Saizen with bacteriostatic water for injection, the mixed medicine may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed medicine after 14 days, even if they still contain medicine.
If your medicine comes in a vial and you mix it with sterile water for injection, use the mixed medicine immediately. Throw away any unused medicine. Do not store mixed medicine for a later time.
If your medicine comes in a Click Easy cartridge and you mix it with sterile water for injection, the mixed medicine may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed medicine after 21 days, even if they still contain medicine.
Do not use Saizen past the expiration date on the container. Contact your pharmacist if you have questions about the proper storage of Saizen. Keep Saizen out of the reach of children and away from pets.
- If you have any questions about Saizen, please talk with your doctor, pharmacist, or other health care provider.
- Saizen 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 Saizen 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 Saizen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Saizen. 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 Saizen.