Regulatory Decision Summary for SMOFKABIVEN PERIPHERAL
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this New Drug Submission was to seek market authorization of SmofKabiven Peripheral as a total parenteral nutrition (TPN) for adult patients when oral or enteral intake is impossible, insufficient, or contraindicated and central catheters are unavailable or contraindicated.
Why was the decision issued?
Health Canada considers that the anticipated benefits of SmofKabiven Peripheral outweigh the potential risks in adult patients when oral or enteral intake is impossible, insufficient, or contraindicated and central catheters are unavailable or contraindicated.
The efficacy of SmofKabiven Peripheral has not been specifically assessed. The efficacy claim for SmofKabiven Peripheral is based on the evidence available for the nutritional efficacy of its individual components (SMOFlipid 20%, Glucose, and Aminoven 10%). These individual components of SmofKabiven Peripheral have been previously evaluated for safety and efficacy during the market authorization process by Health Canada. The effectiveness of glucose as a source of calories has been established decades ago. The efficacy and safety of Aminoven 10% was evaluated previously within the New Drug Submission of SmofKabiven for central infusion.
Patients who were administered SmofKabiven Peripheral during the clinical trials could survive during the period of the trials without any other source of nutrition. Also, no adverse events that could be interpreted as worsening of health status due to insufficient nutrition were observed during the period of treatment with SmofKabiven Peripheral. This indicates that SmofKabiven Peripheral can provide the required nutritional elements to cover nutritional needs of adult patients for whom oral or enteral intake is impossible, insufficient, or contraindicated.
The safety of SmofKabiven Peripheral was assessed with data from clinical trials and post-market experience. The safety of SmofKabiven Peripheral was comparable to the safety of the comparator (Kabiven). The data indicated that SmofKabiven Peripheral was associated with a slightly higher number of adverse events than Kabiven. The most common treatment-emergent adverse events in the SmofKabiven Peripheral pooled group were flatulence, vomiting, nausea, abdominal pain, and dyspepsia. All serious adverse events reported in the SmofKabiven Peripheral group were assessed as unlikely related to SmofKabiven Peripheral.
The tolerance of SmofKabiven Peripheral was assessed by the Modified Maddox Scoring System (MMS) on a scale between 0 and 6. SmofKabiven Peripheral was well tolerated as the MMS scores were low; no rating MMS >3 was observed within 4 hours after the start of administration.
Data from post-market experience (between the first registration of SmofKabiven Peripheral in 2007 and June 2014) indicate that approximately 3.5 million units were sold with approximately 707,000 patients being treated with SmofKabiven Peripheral. All serious adverse events reported in SmofKabiven Peripheral group were assessed as unlikely related to Smofkabiven Peripheral. No actions relating to safety have been taken by regulatory authorities or the marketing authorization holder since the launch of this product in 2007.
In conclusion, Health Canada considers that the benefit/risk ratio of SmofKabiven Peripheral for total parenteral nutrition, as described in the Product Monograph, is favorable at this time.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| SMOFKABIVEN PERIPHERAL | 02456206 | FRESENIUS KABI CANADA LTD | ALANINE 440 MG / 100 ML ARGININE 380 MG / 100 ML CALCIUM CHLORIDE 18 MG / 100 ML DEXTROSE 7.1 G / 100 ML FISH OIL 420 MG / 100 ML GLYCINE 350 MG / 100 ML HISTIDINE 93 MG / 100 ML ISOLEUCINE 160 MG / 100 ML LEUCINE 230 MG / 100 ML LYSINE (LYSINE ACETATE) 210 MG / 100 ML MAGNESIUM SULFATE 38 MG / 100 ML MEDIUM CHAIN TRIGLYCERIDES (MCT) 850 MG / 100 ML METHIONINE 130 MG / 100 ML OLIVE OIL 700 MG / 100 ML PHENYLALANINE 160 MG / 100 ML POTASSIUM CHLORIDE 140 MG / 100 ML PROLINE 350 MG / 100 ML SERINE 210 MG / 100 ML SODIUM ACETATE TRIHYDRATE 110 MG / 100 ML SODIUM GLYCEROPHOSPHATE 130 MG / 100 ML SOYBEAN OIL 850 MG / 100 ML TAURINE 32 MG / 100 ML THREONINE 140 MG / 100 ML TRYPTOPHAN 63 MG / 100 ML TYROSINE 12 MG / 100 ML VALINE 200 MG / 100 ML ZINC SULFATE HEPTAHYDRATE 0.4 MG / 100 ML |