BKEMV REMS Package Insert

Specifications

• Product Name: BKEMV
• Manufacturer: Amgen Inc.
• Application Number: 761333Orig1s000

Product Usage Instructions

• For Patients Prescribed BKEMV:
  • Before Treatment Initiation:
    • Get meningococcal vaccines for serogroups A, C, W, Y, and B as directed by your prescriber.
    • Take antibiotics as directed by your prescriber if you have to start BKEMV right away.
    • Receive counseling from the prescriber using the Patient Safety Card and Patient Guide.
    • Get the Patient Safety Card and Patient Guide from your prescriber.
• During Treatment:
  • Get additional meningococcal vaccines as directed by your prescriber.
• At all times during treatment and for 3 months after the last dose:
  • Have the Patient Safety Card with you.
  • Inform your prescriber or get emergency medical care right away if you experience any of the following symptoms: fever; fever and a rash; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with stiff neck or stiff back; confusion; eyes sensitive to light; muscle aches with flu-like symptoms.
• For Healthcare Settings and Pharmacies Dispensing BKEMV:
  • To Become Certified to Dispense:
    • Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
    • Have the Authorized Representative review the Healthcare Provider Safety Brochure.
    • Enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
    • Train all relevant staff involved in dispensing BKEMV using the Healthcare Provider Safety Brochure.
• Before Dispensing, First Dose:
  • Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.

FAQs

• Q: What should I do if I forget to carry the Patient Safety Card during treatment?
  • A: It is essential to have the Patient Safety Card with you at all times during treatment. If you forget to carry it, contact your prescriber immediately for guidance on obtaining a replacement.
• Q: How can I verify if my prescriber is certified to prescribe BKEMV?
  • A: Before dispensing each prescription, contact the REMS to verify that the prescriber is certified to prescribe BKEMV. This step ensures compliance with safety protocols.

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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
761333Orig1s000
REMS

During treatment At all times

8. Counsel the patient using the Patient Safety Card and Patient Guide. Provide a copy of the materials to the patient.
9. Counsel the patient on the need to carry the Patient Safety Card.
10. Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately if infection is suspected.
11. Vaccinate patients as needed according to the current ACIP recommendations for meningococcal vaccinations for patients receiving a complement inhibitor.
12. Report adverse events suggestive of meningococcal infection, including the patient’s clinical outcomes, to Amgen Inc.

2. Patients who are prescribed BKEMV:

Before treatment initiation

1. Get meningococcal vaccines for serogroups A, C, W, Y, and B as directed by your prescriber.
2. Take antibiotics as directed by your prescriber if you have to start BKEMV right away.
3. Receive counseling from the prescriber using the Patient Safety Card and Patient Guide.
4. Get the Patient Safety Card and Patient Guide from your prescriber.

During treatment

5. Get additional meningococcal vaccines as directed by your prescriber.

At all times during treatment 6. Have the Patient Safety Card with you.

and for 3 months after the last dose

7. Inform your prescriber or get emergency medical care right away if you experience any of the following: fever; fever and a rash; fever with

high heart rate; headache with nausea or vomiting; headache and

fever; headache with stiff neck or stiff back; confusion; eyes sensitive

to light; muscle aches with flu-like symptoms.

3. Healthcare settings and pharmacies that dispense BKEMV must:

To become certified to dispense

1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
3. Have the Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing BKEMV using the Healthcare Provider Safety Brochure.
5. Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.

Reference ID: 5388039

6. For patients who are not up to date with meningococcal vaccines when starting treatment: Establish processes and procedures to assess the patient’s vaccination status for up to date meningococcal vaccines including antibacterial drug prophylaxis, if needed, by contacting the prescriber before dispensing prescriptions up to 6 months after the first dose and document the findings.

Before dispensing, first dose 7. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
8. Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.

Before dispensing, up to

9. Obtain authorization to dispense each prescription by contacting the

6 months after the first dose

REMS to verify the prescriber is certified.

10. For patients who are not initially up to date with meningococcal vaccines when starting treatment: Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.

Before dispensing, 6 months 11. Obtain authorization to dispense each prescription by contacting the

after the first dose and

REMS to verify the prescriber is certified.

thereafter

To maintain certification to dispense

12. If the Authorized Representative changes, have a new Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.

At all times

13. Report adverse events suggestive of meningococcal infections to Amgen Inc.
14. Not distribute, transfer, loan, or sell BKEMV, except to other certified healthcare settings or certified pharmacies.
15. Maintain records of staff’s completion of REMS training.
16. Maintain records that all processes and procedures are in place and are being followed.
17. Comply with audits carried out by Amgen Inc. or a third party acting on behalf of Amgen Inc. to ensure that all processes and procedures are in place and are being followed.

4. Wholesalers-distributors that distribute BKEMV must:

To be able to distribute

1. Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings and pharmacies.
2. Train relevant staff involved in BKEMV distribution on the REMS requirements.

At all times

3. Distribute only to certified healthcare settings and pharmacies. 4. Maintain records of all drug distributions.

Reference ID: 5388039

5. Comply with audits carried out by Amgen Inc. or a third party acting on behalf of Amgen Inc. to ensure that all processes and procedures are in place and are being followed.

Amgen Inc. must provide training to healthcare providers who prescribe BKEMV. The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Safety Card, and Patient Guide. The training must be available online and in hardcopy format via mail.

Amgen Inc. must provide training to healthcare settings and pharmacies that dispense BKEMV. The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available online and in hardcopy format via mail.

To support REMS operations, Amgen Inc. must:

1.

Establish and maintain a REMS Website, www.BKEMVREMS.com. The REMS Website must include

the capability to complete prescriber certification and enrollment by fax, email, and online,

healthcare setting and pharmacy certification and enrollment by fax and email, and the option to

print the Prescribing Information, Medication Guide, and REMS materials. All product websites for

consumers and healthcare providers must include prominent REMS-specific links to the REMS

Website. The REMS Website must not link back to the promotional product website(s).

2.

Make the REMS Website fully operational and all REMS materials available through the REMS

Website and Coordinating Center by the date BKEMV is first commercially distributed.

3.

Establish and maintain a REMS Call Center at 1-866-718-6927.

4.

Establish and maintain a validated, secure database of all certified prescribers, and certified

healthcare settings and pharmacies in the BKEMV REMS.

5.

Ensure that healthcare settings and pharmacies are able to obtain authorization to dispense by

phone and online.

6.

Ensure prescribers are able to enroll by fax, email, and online.

7.

Ensure healthcare settings and pharmacies are able to enroll by fax and email.

8.

Ensure prescribers, and healthcare settings and pharmacies are able to report adverse events

suggestive of meningococcal infections by phone.

9.

Ensure that once a report suggestive of meningococcal infection is received, Amgen Inc. will

follow up with the healthcare providers to obtain all required data. This requirement does not

affect Amgen Inc.’s other reporting and follow-up requirements under the FDA regulations.

10. Provide the Prescriber Enrollment Form, Healthcare Provider Safety Brochure, Patient Safety Card, Patient Guide, Medication Guide, and the BKEMV Prescribing Information to healthcare providers who (1) attempt to prescribe BKEMV and are not yet certified or (2) inquire about how to become certified.

11. Provide the Healthcare Setting and Pharmacy Enrollment Form and Healthcare Provider Safety Brochure to healthcare settings and pharmacies that (1) attempt to order/dispense and are not yet certified or (2) inquire about how to become certified.

12. Notify prescribers, and healthcare settings and pharmacies within 2 business days after they become certified in the REMS.

13. Provide certified prescribers access to the database of certified healthcare settings and pharmacies.

14. Provide certified healthcare settings and pharmacies access to a database of certified prescribers.

15. Provide authorized wholesalers-distributors access to a database of certified healthcare settings and pharmacies.

To ensure REMS participants’ compliance with the REMS, Amgen Inc. must:

16. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: BKEMV distribution and dispensing; certification of prescribers, and

Reference ID: 5388039

Other Materials 7. REMS Website

VI.

Statutory Elements

This REMS is required under Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

1.

Elements to Assure Safe Use:

Healthcare providers who prescribe BKEMV are specially certified under 505-1(f)(3)(A)

Healthcare settings and pharmacies that dispense BKEMV are specially certified under

505-1(f)(3)(B)

BKEMV is dispensed to patients with evidence or other documentation of safe-use conditions

under 505-1(f)(3)(D)

2.

Implementation System

3.

Timetable for Submission of Assessments

Reference ID: 5388039

What is BKEMV?
BKEMV is indicated for the treatment of:
· Patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. · Patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic
microangiopathy.
Limitation of Use
BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Risk of Serious Meningococcal Infections
· BKEMV, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains.
· Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors such as BKEMV.
· The initiation of BKEMV treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection.
· At least 2 weeks prior to administration of the first dose of BKEMV, complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor.
· If urgent BKEMV therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible.
· Vaccination does not eliminate the risk of meningococcal infections, despite development of antibodies following vaccination.
· Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Promptly treat known infections.
· Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. · Inform patients of the signs and symptoms of serious meningococcal infection and instruct patients to
seek immediate medical care if these signs and symptoms occur. · Consider interruption of BKEMV in patients who are undergoing treatment for serious meningococcal
infection, depending on the risks of interrupting treatment in the disease being treated.
What is the BKEMV REMS?
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to help ensure that the benefits of a drug outweigh its risks. Because of the risk of serious meningococcal infections, BKEMV is available only through the BKEMV REMS, a restricted distribution program.

Phone: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
Reference ID: 5388039

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Prescriber Requirements

What do Prescribers Need to do When Prescribing BKEMV?
Healthcare providers who prescribe BKEMV must be specially certified. To become certified in the BKEMV REMS and prescribe BKEMV, prescribers must:
1. Review the BKEMV Prescribing Information, Healthcare Provider Safety Brochure (this document), Patient Safety Card, and Patient Guide.
2. Complete and submit the Prescriber Enrollment Form to the REMS: · online at www.BKEMVREMS.com · by fax at 1-866-718-8244 · by scanning and emailing to Amgen@BKEMVREMS.com

Before initiating a patient’s BKEMV treatment, prescribers must:
· Assess the patient for unresolved meningococcal infections and not initiate BKEMV in any patient with these infections.
· Assess the patient’s vaccination status for meningococcal serogroups A, C, W, Y and B and vaccinate as needed according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
· For patients who are not up to date with meningococcal vaccines at least two weeks prior to initiation of treatment and who must start BKEMV urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
· Counsel the patient using the Patient Safety Card and Patient Guide. Provide a copy of the materials to the patient.
o The Patient Guide provides information for your patients about the risk of serious meningococcal infections including:

The need to complete or update their meningococcal vaccines for serotypes A, C, W, Y, and B at least 2 weeks prior to receiving the first dose of BKEMV or receive antibacterial drug prophylaxis if BKEMV must be initiated immediately, and they have not previously been vaccinated.

Additional vaccines may be necessary during treatment with BKEMV.

Meningococcal vaccines do not prevent all meningococcal infections.
o The Patient Safety Card has important safety information for both patients and any healthcare providers that may see or treat your patient. It describes the following signs and symptoms which, if experienced, should prompt the patient to seek immediate medical care:

fever fever and a rash fever with high heart rate headache with nausea or vomiting headache and fever

headache with stiff neck or stiff back confusion eyes sensitive to light muscle aches with flu-like symptoms

· Counsel the patient on the need to carry the Patient Safety Card. Instruct your patient to show the card to any healthcare provider involved in their care.
o Instruct the patient to carry the Patient Safety Card at all times and for 3 months after their last dose.

Phone: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
Reference ID: 5388039

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During BKEMV treatment, prescribers must:
· Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately if infection is suspected.
· Vaccinate patients as needed according to the current ACIP recommendations for meningococcal vaccinations for patients receiving a complement inhibitor.
At all times, prescribers must:
· Report adverse events suggestive of meningococcal infection, including the patient’s clinical outcomes, to Amgen Inc. at 1-800-772-6436 (1-800-77-AMGEN).
· Comply with the BKEMV REMS requirements to maintain certification to prescribe. Before dispensing, certified healthcare settings and pharmacies must assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B according to the current ACIP recommendations including antibacterial drug prophylaxis, if needed. If you have not provided this information already, you may receive a call from the healthcare setting and pharmacy to collect information confirming that the patient has received the appropriate vaccinations or antibacterial drug prophylaxis.
Healthcare Setting and Pharmacy Requirements
What do Healthcare Settings and Pharmacies Need to Do to Dispense BKEMV?
BKEMV may only be dispensed by healthcare settings and pharmacies that are certified to dispense. To become certified, the healthcare setting or pharmacy must designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy. To become certified, the Authorized Representative must:
· Review the Healthcare Provider Safety Brochure (this document) · Complete and submit the Healthcare Setting and Pharmacy Enrollment Form to the REMS:
o by fax at 1-866-718-8244 o by scanning and emailing to Amgen@BKEMVREMS.com
By completing the Healthcare Setting and Pharmacy Enrollment Form, the Authorized Representative agrees to:
· Train all relevant staff involved in dispensing BKEMV using the Healthcare Provider Safety Brochure. · Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status
for up to date meningococcal vaccines for serogroups A, C, W, Y, and B according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings. · For patients who are not up to date with meningococcal vaccines when starting treatment: Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status for up to date meningococcal vaccines including antibacterial drug prophylaxis, if needed, before dispensing prescriptions up to 6 months after the first dose and document the findings.
Before dispensing the first dose, all healthcare setting and pharmacy staff must:
· Obtain authorization to dispense each prescription by contacting the REMS to verify that the prescriber is certified.
· Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.

Phone: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
Reference ID: 5388039

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Before dispensing, up to 6 months after the first dose, all healthcare setting and pharmacy staff must:
· Obtain authorization to dispense each prescription by contacting the REMS to verify that the prescriber is certified.
· For patients who are not initially up to date with meningococcal vaccines when starting treatment: Assess the patient’s vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, 6 months after the first dose and thereafter, all healthcare setting and pharmacy staff must:
· Obtain authorization to dispense each prescription by contacting the REMS to verify that the prescriber is certified.
At all times, all healthcare setting and pharmacy staff must:
· Report adverse events suggestive of meningococcal infections to Amgen Inc. by phone at 1-800-772-6436 (1-800-77-AMGEN).
· Not distribute, transfer, loan, or sell BKEMV, except to certified healthcare settings or certified pharmacies. · Maintain records for staff’s completion of REMS training. · Maintain records that all processes and procedures are in place and being followed. · Comply with audits carried out by Amgen Inc. or a third party acting on behalf of Amgen Inc. to ensure
that all processes and procedures are in place and are being followed.
To maintain certification to dispense, any new Authorized Representative must:
· Enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
BKEMV REMS Resources
Visit www.BKEMVREMS.com or call 1-866-718-6927 to learn more about the BKEMV REMS.
Adverse Event Reporting
Report adverse events suggestive of meningococcal infections, including the patient’s clinical outcomes, immediately to Amgen Inc. at 1-800-772-6436 (1-800-77-AMGEN). You are encouraged to report other adverse reactions of BKEMV to Amgen Inc. by phone at 1-800-772-6436 (1-800-77-AMGEN) or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
This brochure does not provide all risk information for BKEMV. Please see Prescribing Information for BKEMV, including BOXED WARNING regarding serious meningococcal infections for more detailed safety information.

BKEMVTM is a trademark of Amgen Inc. Copyright© 2024, Amgen Inc. All rights reserved.
Phone: 1-866-718-6927 | www.BKEMVREMS.com | Fax: 1-866-718-8244
Reference ID: 5388039

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Signature Page 1 of 1
——————————————————————————————-This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. ——————————————————————————————–
/s/ ———————————————————–TANYA M WROBLEWSKI 05/28/2024 04:09:41 PM
Reference ID: 5388039

Documents / Resources

BKEMV REMS Package Insert [pdf] Owner's Manual REMS Package Insert, REMS, Package Insert, Insert

References

• User Manual