Certain blister packages of Sandimmune (cyclosporine capsules) and Neoral (cyclosporine capsules) may not meet child-resistant packaging requirements, according to manufacturer Novartis.
The Company announced that it is working with the Consumer Product Safety Commission to address the packaging issue. In a press statement, Novartis stressed that there are no quality or efficacy issues with the drugs and that patients should continue to take their medications as prescribed.
Sandimmune 100mg soft gelatin capsules (Novartis)
Neoral 100mg soft gelatin capsules (Novartis)
To correct the issue, resealable pouches will be provided to patients with the affected product, as well as to pharmacies for when the product is dispensed. This interim measure, the Company stated, will help avoid a potential drug shortage while the new packaging is developed. To receive a free resealable child-resistant pouch, patients can call (866) 629-6182 or email Novartis5060@stericycle.com.
Video courtesy of Novartis.
The affected products include:
- Sandimmune (cyclosporine capsules, USP) 100mg soft gelatin capsules: 100mg 30-count blister packs and liquid filled single capsule blister packs; NDC#0078-0241-15 (carton) and #0078-0241-61 (blister pack); lot number/expiration date: APCA136/Sept 2020; APCA339/Feb 2021; APCA793/Jan 2022; APCC238/July 2022.
- Neoral (cyclosporine capsules, USP) Modified 100mg soft gelatin capsules: 100mg 30-count blister pack and liquid filled single capsule blister packs; NDC#0078-0248-15 (carton) and #0078-0248-61 (blister pack); lot number/expiration date: APCA437/July 2020; APCA979/March 2021.
Sandimmune (cyclosporine capsules, USP) 25mg soft gelatin capsules and Neoral (cyclosporine capsules, USP) Modified 25mg soft gelatin capsules are NOT included in this corrective action.
Sandimmune is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, in combination with corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, in combination with azathioprine and corticosteroids. It is also approved for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Additionally, it is used for the treatment of adult, nonimmunocompromised patients with severe (ie, extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (eg, PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.
For more information call (866) 629-6182 or visit novartis.com.