TM Owner EMD Serono / Merck KGaA
Saizen 8.8mg Injection
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Indications & Clinical Uses
- Saizen 8.8 mg (somatropin) is a recombinant human growth hormone given by injection, used to treat growth failure in children due to growth hormone deficiency, and short stature associated with conditions such as Prader-Willi syndrome or Noonan syndrome depending on the market's approved label; it is also approved for replacement therapy in adults with growth hormone deficiency of either childhood or adult onset.
- Saizen is available as a multidose vial with diluent or as a pre-filled click.easy or saizenprep cartridge for use with a reusable injector pen, allowing self-injection once daily by the patient or a caregiver, typically at bedtime.
- Growth-promoting treatment in children continues until the growth plates (epiphyses) close, while adult replacement therapy is usually long-term.
- It is manufactured for Merck KGaA, Darmstadt, Germany (marketed as EMD Serono in the US and Canada).
Side Effects
- Saizen has no boxed warning.
- In adults, the most frequently reported reactions in trials included joint pain (arthralgia, roughly 1 in 4 people), headache, and peripheral swelling (oedema); muscle pain, tingling sensations (paraesthesia) and carpal tunnel syndrome have also been reported, especially at treatment start.
- Injection-site reactions such as pain, redness, swelling or numbness can occur; rotate the injection site each time.
- Rare but serious reactions include intracranial hypertension, usually within the first eight weeks, causing headache, vision changes, nausea or vomiting; new or worsening high blood sugar or diabetes; and pancreatitis, which causes severe abdominal pain.
- Seek urgent medical attention for severe headache with vision changes, signs of an allergic reaction, or severe stomach pain, and tell your healthcare provider promptly about any new lumps, since long-term treatment requires monitoring for tumour recurrence in cancer survivors.
Precautions & Warnings
- Saizen must not be used in people with active malignancy, acute critical illness (such as after open-heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure), or in children with Prader-Willi syndrome who are severely obese or have severe breathing problems, due to reports of sudden death in this group.
- It should not be given if growth plates have already closed for growth-promotion use, and patients with active or suspected tumours should not start treatment until the tumour is inactive and cancer therapy is complete.
- Diabetic retinopathy should be assessed before and during treatment.
- Saizen can unmask underlying low thyroid or adrenal function, worsen blood sugar control in people with diabetes, and cause slipped hip growth plates or worsening scoliosis in growing children, so regular monitoring is required throughout treatment.
- Discuss use in pregnancy and breastfeeding with your healthcare provider.
Avoid Interactions
- Glucocorticoid (steroid) medicines can reduce the growth-promoting effect of Saizen, so doses of both may need adjusting if used together; conversely, Saizen can unmask a previously hidden lack of adrenal hormone, sometimes requiring glucocorticoid replacement to be started or increased.
- Oral oestrogen, including some contraceptive pills and hormone therapy, can reduce Saizen's effect, and higher somatropin doses may be needed in women taking oral oestrogen.
- Because growth hormone can affect blood sugar, doses of insulin or other diabetes medicines may need adjustment, and blood sugar should be monitored more closely after starting or stopping Saizen.
- Tell your healthcare provider about all medicines and supplements you use, particularly steroids, hormone therapy, diabetes treatments and any other pituitary or thyroid medicines, since dose changes of either medicine may be needed.
References
Frequently Asked Questions
Saizen (somatropin) is a growth hormone injection used to treat growth failure in children with growth hormone deficiency and to replace growth hormone in adults who lack enough of it. Some markets also approve it for Prader-Willi or Noonan syndrome-related short stature. Treatment is prescribed and monitored by a specialist.
Saizen is injected under the skin (subcutaneously), usually once daily at bedtime, using either a reconstituted vial or a pre-filled click.easy or saizenprep cartridge with a pen injector. Rotate the injection site each time. A healthcare provider will show you or your child's caregiver the correct technique first.
The most common effects are joint pain, headache and mild swelling, especially soon after starting. Watch for severe headache with vision changes or vomiting (a sign of raised pressure in the brain), new high blood sugar symptoms, or severe abdominal pain, and contact your healthcare provider urgently if these occur.
Don't start Saizen with an active tumour, acute critical illness, or closed growth plates for growth-promotion use. Steroid medicines can weaken its effect, while oral oestrogen can also reduce it. Tell your healthcare provider about every medicine you take, especially steroids, insulin and hormone treatments.
Keep unopened Saizen vials or cartridges at room temperature, 15°C to 30°C, away from light, not in the fridge. Once mixed with the diluent, refrigerate at 2°C to 8°C and use within 14 days for vials or 21 days for cartridges, and never freeze it.
If a dose is missed, give it as soon as you remember that day; if it's already the next day, skip the missed dose and continue the regular schedule rather than doubling up. Contact your healthcare provider if doses are missed often, since this can affect growth outcomes.
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