What is Saizen?Saizen is a medicine that contains human growth hormone. It is used as a replacement for natural growth hormone in adults with growth hormone deficiency (GHD) and children with growth failure due to GHD. Saizen is administered subcutaneously (just below the skin) and intramuscularly (injected into the muscle) in children.
What is the most important information I should know about Saizen?While you are on Saizen, increased pressure in your brain can occur, and may include papilledema (swelling of the optic disk), visual changes, headache, nausea, and/or vomiting.
If you have tumors or lesions in your brain, you should be monitored for worsening or recurrence of the tumor or lesions. In addition, Saizen can cause a second tumor, especially in your brain, after receiving radiation to your head for the first tumor.
Saizen can increase your blood sugar levels. Check your blood sugar levels regularly. Your doctor may need to adjust the dose of your diabetes medications.
Saizen can also cause or worsen hypothyroidism (an underactive thyroid gland) and cause fluid retention, especially in adults.
In children, Saizen can cause a progression of scoliosis (curving of the spine) or skeletal abnormalities in children with Turner syndrome or Prader-Willi syndrome (rare genetic disorders).
Slip of the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth. Tell your doctor if your child experiences limping or pain in his/her knee or hip.
Saizen can be reconstituted with Bacteriostatic Water for Injection, which contains benzyl alcohol as a preservative. Benzyl alcohol can cause toxicity in your newborn baby. You can use Sterile Water for Injection, but you can use only one dose per vial and discard the unused portion.
Who should not take Saizen?Do not use Saizen if you are allergic to it, any of its ingredients, or benzyl alcohol if you are mixing Saizen with Bacteriostatic Water for Injection. Also, do not use Saizen if you have eye problems caused by diabetes, active cancer, or if you are critically ill with severe breathing problems or with complications following heart or abdominal surgery, or trauma.
What should I tell my doctor before I take the first dose of Saizen?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Saizen. Also, talk to your doctor about your complete medical history, especially if you have a serious medical condition after having an open heart or abdominal surgery, serious injuries involving many body systems, or breathing problems (such as sudden respiratory failure), cancer or other tumors, multiple hormone deficiencies, hypothyroidism, scoliosis, or diabetes.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: Your doctor will prescribe the appropriate dose for you based on your condition or weight.
Children: Your doctor will prescribe the appropriate dose for your child, based on their weight.
How should I take Saizen?Use Saizen exactly as prescribed by your doctor.
Change the sites of injection every day to avoid injection-site reactions (such as redness or pain).
Your doctor will show you and/or your caregiver how to inject this medicine, as well as how to properly dispose syringes and needles. Please review the instructions that came with your prescription on how to properly use Saizen.
What should I avoid while taking Saizen?After mixing, do not shake the vial containing the solution. Do not inject Saizen solution if cloudiness persists after reconstitution or refrigeration.
Do not reuse needles and syringes.
What are possible food and drug interactions associated with Saizen?If Saizen is used with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Saizen with the following: cyclosporine, diabetes medications, glucocorticoids (such as prednisone), insulin, seizure medications, or sex steroids (such as estrogen, progesterone, or testosterone).
What are the possible side effects of Saizen?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: allergic reactions, back pain, breast enlargement, chest pain, depression, dizziness, headache, high blood sugar levels, infections, injection-site reactions, joint or muscle pain, nausea, swelling, swollen hands or feet due to fluid retention
Can I receive Saizen if I am pregnant or breastfeeding?The effects of Saizen during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
What should I do if I miss a dose of Saizen?If you miss a dose of Saizen, inject it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not inject two doses at once.
How should I store Saizen?Store at room temperature. After mixing, store in the refrigerator and use within 14 days. Do not freeze.