Frequently Asked Questions
About Nutropin AQ® (somatropin)
Responses to the Frequently Asked Questions below combine to deliver key clinical, safety, and administrative information on different aspects of Nutropin therapy.
A Nutropin AQ injection device should be stored inside a refrigerator at 36° to 46°F (2° to 8°C). When traveling, the device should be stored within the same temperature range. The device must be kept dry and free from moisture. Do not freeze.
Nutropin AQ is light-sensitive and Nutropin AQ should be protected from light. Store the Nutropin AQ injection device refrigerated in a dark place when it is not in use.
During use, it is recommended to keep Nutropin AQ products outside of the refrigerator for no longer than one hour per day. If Nutropin AQ products are kept outside the refrigerator for longer than one hour, the medication should not be used. Direct patients to call 1-866-NUTROPIN (1-866-688-7674) for additional assistance. When traveling, instruct patients to keep their Nutropin device dry and stored within the appropriate temperature range 36° to 46°F (2° to 8°C).
While taking Nutropin AQ, the patient should contact the prescriber immediately if they experience any of the following symptoms:
- Changes in upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, in patients with Prader-Willi syndrome (PWS). These patients should also have effective weight control and be monitored by a doctor for signs of respiratory infection
- Changes in vision, a bad headache, or nausea with or without vomiting
- A limp or have hip or knee pain
- Progression of scoliosis
- Any allergic reaction to the injection of Nutropin
- Abdominal pain
- Allow the Nutropin AQ to come to room temperature prior to injection
- Rotation of injection site is important. Make sure the patient is using a site where fat can be grasped. This is especially important if the patient is thin
- There are times in which injecting in the thigh can be more comfortable than other injection sites
- The patient should try to keep the muscles in the injection area relaxed during injection
- Sometimes the length of the needle may affect the sensation at the site. An 8mm or longer needle may assist with getting the medication deeper into the tissue. It may be optimal to not use a needle shorter than 6mm
- Make sure the alcohol used to clean the skin has dried completely before injecting
- Ice may be placed on the injection site for a few minutes to numb the area before the injection
- It may be helpful to gently massage the site with a cotton swab or gauze after injection
- The patient may check with a local pharmacist about wipes or swabs that contain a topical anesthetic, though they should ask their prescriber before using
The patient should continue to administer the injections while they are away from home, unless otherwise specified by their prescriber. Nutropin AQ should be protected from light and kept inside the refrigerator or travel cooler, where they can be kept cold (36° to 46°F [2° to 8°C]) but never frozen. Nutropin AQ NuSpin should be used within 28 days after its initial use. If the patient is traveling by plane, they should check with a travel agent or airline to find out about any rules that might affect the transport of medication and injection supplies on board a plane or into another country.More information may be found at these websites:
Missing injections can interfere with the effectiveness of the medication. Remind patients to contact the prescriber for instructions if this should happen.
The patient should inform the HCP of the following:
- Any medications that they are taking, especially if they are taking cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures
- If they have pre-existing tumors or growth hormone deficiency caused by abnormal tissue in the brain
- If they have diabetes, risk factors for diabetes, or impaired glucose tolerance
- If they have hypopituitarism and are on standard hormone replacement therapy
- If they are pregnant, nursing, or plan to become pregnant
Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome.
If a patient experiences side effects or an adverse event, instruct
them to call their healthcare provider for medical advice about side
effects or call Genentech at 1-888-835-2555. In
addition, you may report side effects to the FDA by calling 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.
Undiagnosed, untreated hypothyroidism may prevent an optimal response to GH. Therefore, patients treated with GH should have periodic thyroid function tests, and thyroid replacement therapy should be initiated or appropriately adjusted when indicated. An evaluation of whether the patient is given the correct dosing may be warranted. Testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.
Concomitant glucocorticoid therapy may inhibit the growth promoting effect of GH. Therefore, glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
The length of treatment depends upon the indication and response to GH therapy. It should be continued until the prescriber gives instruction to stop. Reasons to stop treatment may include the following:
- At the prescriber's discretion, which would be determined upon further evaluation
- There is evidence that the patient will not grow any more
- An occurrence of an adverse event
- A patient with chronic kidney disease (CKD) receives a kidney transplant
- Some patients with GHD may need the medication for the metabolic effects throughout adulthood. This would be determined by the prescriber upon further evaluation