AI
Monday, February 27, 2006 12:08:20 PM
Comparison Between iPlex(MECASERMIN RINFABATE RECOMBINANT) and Increlex(MECASERMIN RECOMBINANT) (Tercica, Inc)
A. Preservation
Iplex is a preservative-free solution for subcutaneous injection.
Increlex contains benzyl alcohol as a preservative. Benzyl alcohol as a preservative has been associated with neurologic toxicity in neonates.
(Benzyl Alcohol can cause upper respiratory tract irritation, headaches, nausea and vomiting, a depressed central nervous system and a drop in blood pressumer. Commonly found nail polish remover, air fresheners, bleach, laundry soap and fabric softener, deodorants, soap, and shampoo.)
B. How Supplied
iPlex is temperature sensitive and must be stored frozen at -70°C (-94ºF) while in the distribution chain. The patient must be instructed to keep the medication frozen while transferring it to his/her home freezer (-20°C, -4ºF). Frozen (-70°C) iplex from the distributor can be transported on dry ice to the patient’s home freezer. The medication must remain in the patient’s home freezer until time of use. (How much cost for a freezer? Google key words of "Medical grade freezer".)
Increlex vials are stable when refrigerated [2º to 8ºC (35º to 46ºF)] Before Opening. After Opening – Vials of Increlex are stable for 30 days after initial vial entry when stored at 2º to 8ºC (35º to 46ºF).
C. DOSAGE AND ADMINISTRATION
iPlex dosage and administration should be individualized for each patient. iPlex should be administered via subcutaneous injection at an initial dose of 0.5 mg/kg, to be increased into the therapeutic dose range of 1 to 2 mg/kg, given once daily. iPlex can be given in the morning or in the evening but should be administered at approximately the same time every day and the patient should maintain a regular, balanced diet.
Increlex: Preprandial glucose monitoring should be considered at treatment initiation and until a well tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. The dosage of Increlex should be individualized for each patient. The recommended starting dose of Increlex is 0.04 to 0.08 mg/kg (40 to 80 µg/kg) twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily.
D. OVERDOSAGE
There is no clinical experience with overdosage of both of Increlex and iPlex.
E. Ingredients
IPLEX™
Active ingredient: mecasermin rinfabate (rhIGF-1/rhIGFBP-3)
Inactive ingredients: sodium acetate (CH3COONa), sodium chloride (NaCl)
INCRELEX™
Active ingredient: mecasermin (IGF-1)
Inactive ingredients: sodium chloride (NaCl), polysorbate 20, benzyl alcohol (C7H8O), and acetate (CH3COO-).
F. Administration of Use Porducts
iPlex: Inject IPLEX™ once a day before a meal at the same time every day, either in the morning or in the evening.
Increlex: Inject INCRELEX™ under your child’s skin shortly (20 minutes) before or after a meal or snack.
G. Side Effects
....(a) Hypoglycemia http://www.investorshub.com/boards/read_msg.asp?message_id=9236401
iPlex: Hypoglycemia was reported in 11/36 (31%) patients in the study generally rated as mild and asymptomatic. Baxter Phillips, Insmed spokesman says that iPlex differs from Increlex in that “we’ve not seen any hypoglycemic seizures,” which was a side effect of Increlex. http://www.investorshub.com/boards/read_msg.asp?message_id=9148626
Increlex: Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. 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 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion.
A. Preservation
Iplex is a preservative-free solution for subcutaneous injection.
Increlex contains benzyl alcohol as a preservative. Benzyl alcohol as a preservative has been associated with neurologic toxicity in neonates.
(Benzyl Alcohol can cause upper respiratory tract irritation, headaches, nausea and vomiting, a depressed central nervous system and a drop in blood pressumer. Commonly found nail polish remover, air fresheners, bleach, laundry soap and fabric softener, deodorants, soap, and shampoo.)
B. How Supplied
iPlex is temperature sensitive and must be stored frozen at -70°C (-94ºF) while in the distribution chain. The patient must be instructed to keep the medication frozen while transferring it to his/her home freezer (-20°C, -4ºF). Frozen (-70°C) iplex from the distributor can be transported on dry ice to the patient’s home freezer. The medication must remain in the patient’s home freezer until time of use. (How much cost for a freezer? Google key words of "Medical grade freezer".)
Increlex vials are stable when refrigerated [2º to 8ºC (35º to 46ºF)] Before Opening. After Opening – Vials of Increlex are stable for 30 days after initial vial entry when stored at 2º to 8ºC (35º to 46ºF).
C. DOSAGE AND ADMINISTRATION
iPlex dosage and administration should be individualized for each patient. iPlex should be administered via subcutaneous injection at an initial dose of 0.5 mg/kg, to be increased into the therapeutic dose range of 1 to 2 mg/kg, given once daily. iPlex can be given in the morning or in the evening but should be administered at approximately the same time every day and the patient should maintain a regular, balanced diet.
Increlex: Preprandial glucose monitoring should be considered at treatment initiation and until a well tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. The dosage of Increlex should be individualized for each patient. The recommended starting dose of Increlex is 0.04 to 0.08 mg/kg (40 to 80 µg/kg) twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily.
D. OVERDOSAGE
There is no clinical experience with overdosage of both of Increlex and iPlex.
E. Ingredients
IPLEX™
Active ingredient: mecasermin rinfabate (rhIGF-1/rhIGFBP-3)
Inactive ingredients: sodium acetate (CH3COONa), sodium chloride (NaCl)
INCRELEX™
Active ingredient: mecasermin (IGF-1)
Inactive ingredients: sodium chloride (NaCl), polysorbate 20, benzyl alcohol (C7H8O), and acetate (CH3COO-).
F. Administration of Use Porducts
iPlex: Inject IPLEX™ once a day before a meal at the same time every day, either in the morning or in the evening.
Increlex: Inject INCRELEX™ under your child’s skin shortly (20 minutes) before or after a meal or snack.
G. Side Effects
....(a) Hypoglycemia http://www.investorshub.com/boards/read_msg.asp?message_id=9236401
iPlex: Hypoglycemia was reported in 11/36 (31%) patients in the study generally rated as mild and asymptomatic. Baxter Phillips, Insmed spokesman says that iPlex differs from Increlex in that “we’ve not seen any hypoglycemic seizures,” which was a side effect of Increlex. http://www.investorshub.com/boards/read_msg.asp?message_id=9148626
Increlex: Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. 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 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion.
Peace!
C-Starz
