Clofazimine

Lamprene (generic name clofazimine) manufactured by Novartis, is FDA approved for the treatment of leprosy, but has not been available through traditional pharmaceutical distribution since 2004. The safety and effectiveness of Lamprene for the treatment of other nontuberculous mycobacterial (NTM) infections has not been established.

UPDATED INFORMATION AS OF OCTOBER 2018: The following information applies to requests for new and established FDA authorized single patient investigational new drug (SPINDs) for clofazimine. The process for receiving clofazimine under the Novartis Expanded Access Non-Tuberculous Mycobacterium (NTM) IND has not changed.

Effective October 1, 2018, the National Hansen’s Foundation will no longer be distributing Lamprene/clofazimine for your SPIND patient(s). Novartis Pharmaceuticals will be the distributor of drug for your SPIND patients.

PROCESS TO RECEIVE CLOFAZIMINE:

The process for requesting an SPIND# from the FDA has not changed [see below]. What has changed is as follows.

NOVARTIS WILL REQUEST THE FOLLOWING:

• As a treating physician, you will need to send an email to the following email address: cl***********************@no******.com – along with the completed site contact information form (click here for the form), the SPIND# and the FDA issued acknowledgement letter to request drug supply for your patient.
• Novartis will ask each physician to sign a Managed Access Agreement and supply a current Medical License prior to shipment of Clofazimine. Novartis can provide you with additional information regarding this agreement.
• Novartis will also request that you sign a Physician Attestation form for each patient. This form attests that there is IRB approval, that the patient has signed the informed consent, and that the physician has read and understands the product information and safety reporting responsibilities.
• In addition to the responsibility of treating physicians to submit safety reports to the FDA, Novartis may request that you provide them with safety reports.

SHIPPING LABEL: You will no longer be required to supply a prepaid UPS label for shipment. Novartis will ship the drug to you from their account.

FOR REFILLS:

• Future refills will be arranged by contacting Novartis directly at the above email address. You will no longer be required to contact the FDA with refill requests.
• If you have a patient currently on treatment (SPIND# already issued) you will need to provide Novartis with the SPIND# and FDA Acknowledgement Letter to receive the initial refill from Novartis.
• Even if your patient does not require a refill at this time, we urge you to contact Novartis with the completed site contact information form and IND acknowledgement letter, and complete the registration process with Novartis as soon as possible.

VISIBLE CHANGES:

There will be no changes to the medication (capsules), however, there will be a new label on the medication bottle.

Options for requesting access to Clofazimine

OPTION #1 (NOVARTIS) – FOR NTM PATIENTS NOT CURRENTLY BEING TREATED UNDER AN EXISTING SINGLE PATIENT IND (SPIND) AND WHO ARE ELIGIBLE FOR THE NOVARTIS PROGRAM:

Novartis Pharmaceuticals Corporation is the sponsor of a Clofazimine Expanded Access Program (EAP) in the United States for patients 18 years of age or older with nontuberculous mycobacterial (NTM) infections. This program is intended only for new eligible patients who are not currently being treated under an existing Single Patient IND (SPIND).

Patients currently being treated are not eligible for transfer into the Expanded Access program, but treatment under their existing SPIND may continue (see Option #2 below).

Physicians who believe that their patient may qualify for the Novartis EAP should contact: Novartis Pharmaceuticals Corporation at 1-888-NOW-NOVA (1-888-669-6682), Monday-Friday, 8:30 am – 5 pm EST. Listen for Medical Professionals and press 1, then listen for Medical Information and press 3, then listen for “all other products” and press 2. Any Medical Information Associate can assist with Lamprene/clofazimine inquiries.

Please note: Novartis Pharmaceuticals Corporation is not responsible for the content of this webpage or website.

Option #2 (FDA) – FOR PATIENTS WHO ARE NOT ELIGIBLE FOR THE NOVARTIS NTM PROGRAM:

The healthcare provider goes through their hospital Independent Review Board (IRB) and then submits an individual IND to the FDA for the patient requiring the drug.

Required Documents

1. FDA Forms [Note that a letter of authorization is not required from Novartis]:
2. Form FDA 3926 (PDF) / Form FDA 3926 Instructions OR
3. Form FDA 1571 (PDF) / Form FDA 1571 Instructions AND Form FDA 1572 (DOC) / Form FDA 1572 Instructions
4. FDA DAIP Single Person IND Form (DOC)
5. Doctor’s CV
6. Current lab results for the patient (CBC, chemistries, sensitivity data)
7. Signed informed consent document
8. Submit forms via email to al************@fd*.gov and lo*********@fd*.gov or alternatively by fax to 301-796-9887

FDA will review the information submitted and determine if an SPIND will be issued. If issued, physician will receive from FDA, via email, the SPIND# and a copy of the SPIND Acknowledgement Letter. The physician should then follow the steps above under “PROCESS TO RECEIVE CLOFAZIMINE“.