Guides & Brochures

These guides and brochures serve as tools to aid families' understanding of the diagnosis and treatment of children with severe Primary IGFD. They can be downloaded, printed and distributed to your patients:

• Doctor Discussion Guide
• Guide to Talking with Your Child
• Guide to Living with Severe Primary IGFD
• Excitement Is Growing
• CDC Growth Charts

These guides and brochures are intended for families of children who have been prescribed Increlex^®, but may not reflect all of the safety and efficacy information related to Increlex. For more information, please see the full Prescribing Information for Increlex.

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Downloadable Brochures and Guides

	Doctor Discussion Guide Your patients may already be using this guide to enhance the discussion in your office. This guide assists patients with information and questions to ask during visits with a doctor. Download Now »		CDC Growth Charts Track growth consistent with the charts issued by the US Department of Health and Human Services, Centers for Disease Control and Prevention. Download Now »
	Guide to Talking with Your Child This guide is designed to help answer questions children may have about severe Primary IGFD and its treatment. The questions and suggested responses may be useful for parents and caregivers when communicating important information to their children. Download Now »		Guide to Living with Severe Primary IGFD When a patient is diagnosed with severe Primary IGFD, parents and caregivers have many questions about treatment, support and available resources. This guide provides valuable information for families and caregivers regarding their child's physical and emotional needs after the diagnosis of severe Primary IGFD. Download Now »
	Building Hope for Success Patients and caregivers can benefit from the guide Building Hope for Success, which offers tips on easing fears surrounding the injection process. Download Now »		Excitement Is Growing This informative brochure illustrates many of the attractive features of Increlex.com, including the Growth Tracker tool, disease and product information, and valuable materials and tools to assist you in dealing with severe Primary IGFD. Download Now »
	Download the Updated SMN To get patients started on Increlex, Download the Referral Form, complete it in its entirety and fax the form to PACESM Download Now »		Full Prescribing Information Download the Full Prescribing Information for Increlex. Download Now »

Indication and Important Safety Information

INCRELEX^® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH). Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.

INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.

Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

INCRELEX is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops. INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions and Adverse Reactions]. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX has insulin-like hypoglycemic effects and should be administered 20 minutes before or after a meal or snack. Hypersensitivity and allergic reactions have been reported, including a low number of cases indicative of anaphylaxis requiring hospitalization. Intracranial hypertension has occurred in patients treated with INCRELEX. Funduscopic examination is recommended at the initiation of and periodically during the course of therapy. Patients should have periodic examinations to rule out potential complications from tonsillar/adenoidal hypertrophy and receive appropriate treatment if necessary. Children with onset of limp or hip/knee pain should be evaluated for possible slipped capital femoral epiphysis. Monitor any child with scoliosis for progression of the spine curve.

In clinical studies of 71 pediatric subjects with severe Primary IGFD representing 274 patient-years of treatment, no subjects discontinued due to adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy with INCRELEX. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX. Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX treatment. INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

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For Full Prescribing Information, click here.