• Print

Answers to frequently asked questions about GH therapy

Questions regarding growth hormone deficiency (GHD)

Click questions to see answers.

What causes GHD?

A: GHD occurs when the pituitary gland does not make enough GH. This problem may be present at birth, and is the result of the pituitary gland or hypothalamus not functioning normally (also known as hypopituitarism). If GH is the only hormone that is affected, the condition is referred to as isolated GHD. Acquired GHD may be caused by damage to the pituitary at any time after birth. Decreased pituitary gland function leading to GHD may be caused by a brain tumor, cranial and/or spinal radiation treatment for cancer, severe head trauma, infection, or surgical removal of the pituitary gland. Sometimes no specific cause for the GHD can be found. This is called idiopathic GHD.^5,6

What is hypopituitarism and can patients with GHD also have other pituitary hormone deficiencies?

A: Yes, patients with GHD may have other hormone deficiencies. Hypopituitarism is the decrease or absence of one or more of the pituitary hormones; these hormones may include: GH, adrenocorticotropic hormone (ACTH), thyroid stimulating hormone (TSH), gonadotropins such as luteinizing hormone (LH) and follicle stimulating hormone (FSH), and antidiuretic hormone (ADH).^4,5 Patients with GHD, who also have deficiencies in these hormones, may have additional medications prescribed to provide adequate hormone replacement. These patients need to be followed closely by an endocrinologist.

What causes adult-onset GHD?

A: In adults, GHD may often result when the pituitary gland becomes diseased or damaged. Particular tumors of the pituitary gland (pituitary adenomas), physical injury to the brain (hemorrhage, trauma, surgery), or radiation therapy can all injure the pituitary gland severely enough to cause GHD. Children who receive GH therapy may need to continue with the therapy into adulthood if AGHD is confirmed. Adult-onset GHD has been estimated to affect 1 per 100,000 people annually.⁷

What is a DEXA scan?

A: Dual-energy x-ray absorptiometry (DEXA) is a special kind of x-ray that uses a very low amount of radiation. It is the method used to determine body composition and bone density.⁸ Patients with AGHD may experience changes in bone density and body composition so a baseline measurement may be an important assessment prior to beginning therapy

Back to top

Questions regarding Turner syndrome

Click questions to see answers.

What is Turner syndrome (TS)?

A: TS is a genetic condition in females that results from a missing or an abnormal X (female) chromosome. Many physical features are associated with TS, but few females have all of the features. However, nearly all girls with TS have abnormal growth. Even though their bodies typically produce an adequate level of growth hormone, they do not grow normally and will have a significantly lower than average adult height if not treated.⁹

Back to top

Questions regarding chronic renal insufficiency (CRI)

Click questions to see answers.

How does CRI affect a child's ability to grow?

A: Growth failure is a common and clinically significant concern in children with CRI. Children with CRI typically have increased GH levels but show reduced responsiveness to endogenous GH and insulin-like growth factor-I (IGF-I). An abnormal GH-IGF-I axis, coupled with a variety of nutritional and metabolic problems, is thought to be the underlying etiology of growth disorders seen in this patient population.^10-13

Are there additional concerns for patients with CRI who are on GH therapy?

A: Patients with CRI may have conditions such as avascular necrosis and/or renal osteodystrophy, which puts them more at risk to develop hip or knee pain and/or a limp. If the patient experiences these symptoms they should notify their prescriber.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a smaller number of patients treated with GH products. Symptoms usually occurred within the first weeks of the initiation of GH therapy. In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the GH dose. Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH therapy. If papilledema is observed by funduscopy during GH treatment, treatment should be stopped. If GH-induced IH is diagnosed, treatment with GH can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome and CRI patients may be at increased risk for development of IH.

Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.

How should the timing of injections be handled with CRI patients on dialysis?

A: To optimize therapy for CRI patients who require dialysis, the following guidelines for an injection schedule are recommended:

• Hemodialysis patients should receive their injection at night, just prior to going to sleep or at least 3 to 4 hours after hemodialysis. This helps to prevent the GH injection from causing a hematoma due to heparin exposure during dialysis
• Chronic cycling peritoneal dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis
• Chronic ambulatory peritoneal dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange. HCPs should assess the patient's overall treatment plan to determine the best time of day to habitually administer Nutropin therapy

Back to top

Questions regarding Nutropin therapy

Click questions to see answers.

Are there any safety concerns for a patient on GH therapy?

A: Patients may experience discomfort, soreness, or redness where Nutropin is injected.

Pediatric Patients

• Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth
• Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy
• Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis

Adult Patients

• GH therapy may cause fluid retention
• Carpal tunnel syndrome, arthralgia and other joint disorders have been reported in GH-treated patients

If a patient experiences side effects or an adverse event, instruct them to call the HCP. They are also encouraged to report this information to the FDA at 1-800-FDA-1088.

If the HCP becomes aware of a patient having an adverse event, he or she should call the FDA at 1-800-FDA-1088 or contact Genentech Drug Safety/Adverse Events at 1-888-835-2555.

How long should pediatric patients take GH therapy?

A: 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 CRI 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.

How is Nutropin administered?

A: Nutropin is injected into the subcutaneous tissue (the fatty layer under the skin). Each patient needs to be instructed on the method of administration that has been prescribed, whether it is with a Nutropin AQ device or with the syringe.

Why must Nutropin be given by injection?

A: Nutropin must be given by injection because it is a protein. If the medication were taken by mouth, it would be broken down by digestion in the stomach and intestines and would never get to the rest of the body to do its job.

What if a patient misses an injection?

A: Missing injections can interfere with the effectiveness of the medication. Remind patients to contact the prescriber for instructions if this should happen. Patients should not double the dose to make up for a missed injection.

What sites should the patient use for injection?

A: The medication should be given subcutaneously as ordered per the prescriber. Suggested injection sites include the back of the upper arms, upper thighs, upper buttocks, and abdomen. It’s important that patients alternate injection sites to minimize tissue atrophy (or wasting).

Why should injection sites be rotated?

A: Injection site discomfort has been reported. It's important that patients rotate the injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time. Even if a patient develops a preference for one site over another, alternating injection sites with each injection helps to reduce the chances of problems developing at the injection site. Remind patients to notify the Prescriber if any of the following symptoms are noticed at an injection site:

• A lump that doesn't go away
• Bruising that doesn't go away
• Any signs of infection or inflammation at an injection site (such as swelling, pus, persistent redness or pain, or skin that is hot to the touch)

Can patients travel while on Nutropin therapy?

A: Patients should continue to administer the injections while they are away from home, unless otherwise instructed by their prescriber. Nutropin AQ is light sensitive and the vial, cartridges, and Nutropin AQ NuSpin should be protected from light and kept cold (2°-8°C/36°-46°F) but NEVER FROZEN. Advise patients to bring their own needles, as needles from other countries vary. Also, remind patients to check with their 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.

Please see additional information about proper needle disposal and how to travel with GH medication.

What should be done with the needles after an injection is given?

A: The patient/caregiver should dispose of needles in a proper sharps disposal container. Improper disposal of needles and other medical sharps can cause needle-stick injuries, especially for garbage collectors. Advise patients to throw used needles away safely. Needles, sharps, or sharps containers should not be included in household trash. Collection programs for these items are available in many locations throughout the country. The specialty pharmacy (SP) or local health department may also be able to advise patients on disposal of containers.

The Coalition for Safe Community Needle Disposal is a coalition of businesses, community groups, nonprofit organizations, and the government that promotes public awareness and solutions for safe disposal of needles, syringes, and other sharps in the community. The Coalition website provides a searchable database of locations that accept used sharps. Patients can search for locations by visiting www.safeneedledisposal.org/.

Please see additional information about proper needle disposal and how to travel with GH medication.

Will the patient stay on the same dose throughout treatment?

A: The Nutropin dosage and administration schedule should be individualized for each patient.

For children, the medication dose is based on the weight and indication for GH therapy. As a child's weight changes, the prescriber may adjust the dose.

For adult patients, the recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients under 35 years old and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I levels may be used as guidance in dose titration. If an adult experiences headaches, hand/feet swelling, or pain/swelling of joints, the prescriber may stop GH treatment for a while and then restart at a lower dosage.

During treatment with GH, blood tests may be performed periodically in order to be able to make adjustments to the GH dose. Certain proteins (like IGF-I) that are directly influenced by the amount of GH given will be measured. This is done for safety reasons.

At what time of day should Nutropin therapy be administered?

A: It is recommended that the patient establish a consistent routine for the timing of the injection. For example, every night at bedtime or right before dinner every night may be easy to remember. Though, if the patient is on dialysis, there are different recommendations.

Who should not take Nutropin?

A:

• Nutropin should not be used for growth promotion in pediatric patients with closed epiphyses
• Nutropin should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy
• In general, Nutropin should not be used in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Nutropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment
• Nutropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
• Nutropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure
• Nutropin should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of GHD, Nutropin is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome

What other additional information should the patient consider?

A: The prescriber is the primary source of information. Patients should discuss the potential benefits and risks of GH treatment with their prescriber so that they are familiar with possible side effects. The patient should also review all their current medications, particularly corticosteroids (like prednisone or hydrocortisone), sex steroids (like estrogens or testosterone), seizure medication, or cyclosporine.

The prescriber should be aware of or notified if the following occurs with the patient:

• Treated at a hospital for any reason
• An allergic reaction, such as itching, rash, redness, or swelling at the injection site
• Development of a limp or worsened curvature of the spine, or complaints of hip or knee pain
• Has diabetes, as GH may affect the body's response to insulin
• Has symptoms of bad headache, visual changes, nausea, and/or vomiting
• Experiences swelling of the hands and feet (edema)
• Pain and swelling of the joints
• The patient becomes pregnant or is nursing an infant while on GH therapy

Who should the patient contact if he or she experiences a side effect or adverse event?

A: If a patient experiences side effects or an adverse event, instruct them to call the healthcare professional (HCP). They are also encouraged to report this information to the FDA at 1-800-FDA-1088.

If the HCP receives information from a patient that indicates he or she is experiencing an adverse event, what should be done?

A: If the HCP becomes aware of a patient having an adverse event, he or she should call the FDA at 1-800-FDA-1088 or contact Genentech Drug Safety/Adverse Events at 1-888-835-2555.

Where should families and patients be directed when they have reimbursement questions?

A: Patients and families should call Nutropin GPS at 1-866-NUTROPIN (1-866-688-7674) to receive help with reimbursement.

Where can the patient obtain additional educational materials if there is more than one caregiver or household per patient?

A: To request additional educational materials call the Nutropin support line toll free at 1-866-NUTROPIN (1-866-688-7674).

Back to top