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Lenalidomide Suspension 1.25 mg/mL

in Extemporaneous Formulations
Authors:
Rita K. Jew
,
Winson Soo-Hoo
,
Elham Amiri
, and
Jamie M. Gomes
Free access

INGREDIENTS:

Lenalidomide 5 mg capsule5 capsules
Sterile water for irrigationQSAD: 20 mL

EQUIPMENT AND SUPPLIES:

Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), graduated cylinder, beaker, hot plate, thermometer

PREPARATION DETAILS:

Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.

  1. Place capsules in a 30-mL oral syringe.

  2. Add hot water (55°C) to the oral syringe.

  3. Let mixture stand for 10 minutes.

  4. Shake well to mix.

Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).

Labeling Requirements — Extemporaneously compounded preparation. Caution: hazardous drug. For oral use only. Store at room temperature. Shake well before use.

Storage Conditions/Stability — Store at room temperature. Stable for 24 hours.

STABILITY STUDY DETAILS:

Study Container Type — Plastic syringe

Referenced Manufacturer — Lenalidomide capsules (Celgene Corp); sterile water for irrigation (not specified).

Stability-Indicating Study — No

REFERENCE

1.

Morita TO, Yamaguchi A, Kimura S, et al.Stability of lenalidomide suspension after preparation by a simple suspension method for enteral tube administration. J Oncol Pharm Pract. 2016;22(4):579583.

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