Injection Information

Watch: How to Inject Increlex
View the injection process to learn more.

How to Inject Increlex^®

Parents may have some anxiety about administering Increlex injections to their children. Increlex injections are administered twice daily at breakfast and dinner, if possible, since meals are required within 20 minutes of injection.¹ The dosage of Increlex should be individualized for each patient.¹ For more information on titration and dosing click here.

You and your patients' caregivers must keep in mind important considerations about injections¹:

• Increlex should be refrigerated or kept cool — between 35°F and 46°F. Never freeze Increlex.
• Liquid in the vial should be clear and colorless. It should not be used if cloudy or if particles are floating
• Ensure the date marked on the vial is not more than 30 days old.
• Remove only the blue cap. Do not remove the rubber stopper
• Date of use should be recorded on side of vial
• Increlex can be used for up to 30 days after a vial is opened
• Top of vial should be cleaned each time it is used with alcohol wipe, in order to prevent germs from entering the bottle

Help your patient determine the best sites for injection and remind patients to rotate these injection sites.^1,35 Patients should clean the site with alcohol wipes or soap and water before each injection.^1,35

Ensure proper dose is administered based on most recent evaluation of height and weight.

You may want to demonstrate the preparation of the syringe to your patient or caregiver. Prepare the syringe by pulling back the plunger and drawing back the same amount of air as the amount of Increlex.³⁵ Next, inject air into the vial and then draw Increlex into the syringe.³⁵ Check for air bubbles.³⁵

Injecting Increlex

Your patient and/or the parent/caregiver of your patient will need to do the following to properly inject Increlex:

• Lightly pinch the skin for injection
• Hold the syringe firmly at 90-degree angle

• With steady hand, inject Increlex
• Press finger or cotton ball on injection site and hold for 5 seconds (no need to cover injection site)
• Place the vial back into the refrigerator or recommend use of travel kit for storage with gel pack
• Dispose of syringe properly. It should not be recapped and should not be re-used. Syringes and needles are only to be used once and then placed in red sharps container located in safe place.
• Remind patients to use the Safe-Clip when traveling
• Remind patients of applicable law regarding medical waste disposal

View the injection process. Watch the Increlex injection video.

An additional resource for you and your patients is our guide Building Hope for Success, which offers tips on easing fears surrounding the injection process. Download the guide here.

Review potential side effects with your patients. For more information click here. Your patients can get the most out of Increlex therapy by remembering to inject twice a day, every day and to rotate injection sites.¹

Contact PACE^SM at 1-866-435-5677 or download the PACE brochure to learn more.

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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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