Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents. Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg. Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg. 6.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Citric acid anhydrous Sodium citrate dihydrate Sodium chloride Sucrose L-Lysine hydrochloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life 3 years 6.4 Special precautions for storage Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light.
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature. Do not warm in any other way. Immediate use is then recommended. Erelzi may be stored at temperatures up to a maximum of 25 °C for a single period of up to four weeks; after which, it should not be refrigerated again. Erelzi should be discarded if not used within four weeks of removal from refrigeration.
6.5 Nature and contents of container Erelzi solution for injection in pre-filled syringe Clear type I glass syringe with a stainless steel 29 gauge 12.7 mm needle with a needle guard with finger flange, a rubber needle cap (thermoplastic elastomer) and a rubber plunger stopper (bromobutyl rubber), containing 0.5 ml or 1.0 ml of solution. Cartons contain 1, 2 or 4 pre-filled syringes. 30