; (21.0, 38.5)
Complete Response
(CR), n (%) 0 (0.0) 1 (0.9)
Partial Response (PR), n
(%) 8 (7.4) 32 (28 .3)
Duration of Response
(DOR)
Median (months) NE 7.4
95% CI for DOR
(months) NE (5.1, 9.2)
REFERENCES
1. OSHA Hazardous Drugs. OSHA. [Accessed on 29 January 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
How Supplied/Storage and Handling
How Supplied
Dark blue opaque cap and yellow opaque body imprinted “POML” on the cap in white ink and “1 mg” on the body in black ink
1 mg bottles of 21
1 mg bottles of 100
Dark blue opaque cap and orange opaque body imprinted “POML” on the cap and “2 mg” on the body in white ink
2 mg bottles of 21
2 mg bottles of 100
Dark blue opaque cap and green opaque body imprinted “POML” on the cap and “3 mg” on the body in white ink
3 mg bottles of 21
3 mg bottles of 100
Dark blue opaque cap and blue opaque body imprinted “POML” on the cap and “4 mg” on the body in white ink
4 mg bottles of 21
4 mg bottles of 100
Storage
Store at 20°C -25°C (68°F -77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature].
Handling and Disposal
Care should be exercised in handling of Pomalyst. Pomalyst capsules should not be opened or crushed. If powder from Pomalyst contacts the skin, wash the skin immediately and thoroughly with soap and water. If Pomalyst contacts the mucous membranes, flush thoroughly with water.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published1.
Patient Counseling Information
See FDA- approved Patient labeling (Medication Guide)
Embryo-Fetal Toxicity
Advise patients that Pomalyst is contraindicated in pregnancy [see Contraindicatons (4)]. Pomalyst is a thalidomide analog and may cause serious birth defects or death to a developing baby. [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
•Advise females of reproductive potential that they must avoid pregnancy while taking Pomalyst and for at least 4 weeks after completing therapy.
•Initiate Pomalyst treatment in females of reproductive potential only following a negative pregnancy test.
•Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use two different forms of contraception including at least one highly effective form simultaneously during Pomalyst therapy, during therapy interruption and for 4 weeks after she has completely finished taking Pomalyst. Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch or implants) and a partner’s vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm and cervical cap.
•Instruct patient to immediately stop taking Pomalyst and contact her doctor if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if s |
