ZINPLAVA™ (bezlotoxumab) Locator

ZINPLAVA Infusion Center Locator

Help patients and health care providers looking for ZINPLAVA infusion centers by signing up to submit your information for possible inclusion in the ZINPLAVA Infusion Center Locator (ZICL). The ZICL will allow patients and health care providers to search for infusion centers administering ZINPLAVA within a geographic location.

It is anticipated that the ZICL will include the infusion center name, address, phone number(s), and website if provided. The inclusion of any infusion center location in the ZICL is not an endorsement, referral, or recommendation from Merck of the infusion center location, nor is Merck making representations or guarantees about the qualifications, competence, or skills of any infusion center.

What do I need to do to be a Participant in the ZINPLAVA Infusion Center Locator?

To be included in the ZINPLAVA Infusion Center Locator, an infusion center must:

Have a current valid state license to stock and administer ZINPLAVA.
Adhere to all applicable state and federal laws for the stocking and administration of ZINPLAVA to appropriate patients.
At the time of a patient’s scheduled appointment, have in inventory a sufficient quantity of ZINPLAVA to administer to the patient consistent with the prescription written by the patient’s health care provider.
- Infusion center is expected to purchase ZINPLAVA from an authorized distributor of the product in accordance with the applicable terms and conditions of sale.
Contact Merck in the event that the infusion center’s licensing information, name, address, phone, and/or web site is changed or updated or the infusion center’s point of contact for communications from the ZINPLAVA Infusion Center Locator changes.
Agree to receive communications via telephone, mail, and/or email from Merck or companies working for Merck, about the ZICL.

For complete details, see the Terms and Conditions for Participation in the ZINPLAVA Infusion Center Locator. You will need to review and agree to the Terms and Conditions prior to submitting information for the ZINPLAVA Infusion Center Locator. To review the Terms and Conditions, click the “NEXT” button below.

How do I begin?

Compile information on the following, which will be requested during the application process:

Infusion Center location address details, including infusion center name and number, address, city, state, ZIP code, phone number, and website address (if available).
- This information will be displayed on the relevant ZICL website and may appear on related printed materials.
Infusion Center License number.
- Complete an electronic application for each infusion center location.
- Be sure to include the exact license number, including leading zeros, in your entries.
State of Licensure for infusion center and infusion center license name and address information.

Click “NEXT”. To submit your center for possible inclusion in the ZINPLAVA Infusion Center Locator, review and accept Terms and Conditions for Participation in the ZINPLAVA Infusion Center Locator, then enter your center information.

Step 1: Agree to Terms

Please read carefully the Terms and Conditions which govern inclusion in the ZINPLAVA Infusion Center Locator. You acknowledge that by clicking on the I AGREE check box on the next page, you intend to create an electronic signature that has the same legal force and effect as a handwritten signature and thereby indicates your acceptance on behalf of the entity submitting its information for Participation in the ZINPLAVA Infusion Center Locator (if agreed, the "Participant"), and agreement with the Terms and Conditions for Participation in the ZINPLAVA Infusion Center Locator, (the “Terms and Conditions”).

Please note that the person submitting the Infusion Center location information must be the same person agreeing to be a point of contact for the Infusion Center location for communications about the ZICL.

TERMS AND CONDITIONS FOR PARTICIPATION IN THE ZINPLAVA^TM (bezlotoxumab) INFUSION CENTER LOCATOR MAY 2018

The ZINPLAVA Infusion Center Locator (the ZICL) administered by Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is governed by the following Terms and Conditions:

Terms and Conditions

The ZICL is intended to provide health care professionals (“HCPs”) and patients with a means of identifying infusion centers that provide ZINPLAVA within a geographic area. Merck will exercise its discretion whether and when to provide listings for particular geographic areas, and may exercise its discretion not to provide listings for certain geographic areas.

Infusion Centers accepted for enrollment in the ZICL (“Participants”) will be listed in a directory that shall be made available to HCPs and patients. The ZICL will include information provided by Participant including, but not limited to Participant’s name, address, phone, and website (if available). HCPs and patients will be able to search for outpatient infusion center locations within their geographic location.

Enrollment Process:

The opportunity to participate in the ZICL is being made available by Merck to infusion centers that meet the eligibility requirements defined below as determined by Merck. Enrollment in ZICL is obtained by going through a formal approval registration with Merck that includes: 1) completing the online registration form and agreeing to the ZICL terms and conditions (the "Terms and Conditions") as set forth herein; and 2) submitting state licensure for validation by Merck for each infusion center location that you wish to be enrolled in ZICL.

ZICL Eligibility Requirements:

In order to be included in the ZINPLAVA Infusion Center Locator, an infusion center must:

a) Have a current valid state license to stock and administer ZINPLAVA.
b) Adhere to all applicable state and federal laws for the stocking and administration of ZINPLAVA to appropriate patients.
c) At the time of the patient’s scheduled appointment, have in inventory a sufficient quantity of ZINPLAVA to administer to the patient consistent with the prescription written by the patient’s healthcare provider. Infusion center is expected to purchase ZINPLAVA from an authorized distributer of the product in accordance with the applicable terms and conditions of sale.
d) Contact Merck in the event that the infusion center’s licensing information, name, address, phone, and/or website is changed or updated or the infusion center’s point of contact for communications from the ZINPLAVA Infusion Center Locator changes.
e) Agree to receive communications via telephone, mail and/or email from Merck, or companies working for Merck, about the ZICL.

Termination:

Merck reserves the right to terminate the ZICL at any time in its sole discretion. Merck shall provide written notice to enrolled Participants by mail or email in the event it chooses to terminate the ZICL. Merck reserves the right to immediately terminate any Participant's enrollment in the ZICL in the event of a breach of the Terms and Conditions by Participant.

Participant may terminate enrollment in the ZICL at any time upon providing Merck with written notice via email at: MerckZICL@merck.com. Upon receipt of such notice, Merck shall remove Participant’s contact information from all ZICL-related materials within Merck's control and website as soon as reasonably possible.

Changes to the Program:

Merck reserves the right to make changes to the ZICL in its sole discretion at any time by providing notice to enrolled Participants as soon as reasonably possible.

Publicity:

Participant agrees not to use or reference the ZICL or Merck, or any logo, trademark, image, direct or indirect quote or other intellectual property of Merck in any document, website, advertising, sales promotion, press release or other written or verbal communication without the prior written consent of Merck. In addition, Participant shall not state or imply in any document, website, advertising, sales promotion, press release, or other written or verbal communication that its inclusion in the ZICL represents an endorsement, referral or recommendation of Participant by Merck.

Use of Participant’s Information:

Participant agrees to allow Merck to use Participant’s name, address, phone number, website, and other information provided by Participant to Merck, including all trademarks and other intellectual property associated with such Participant’s name and such information on all ZICL-related materials, including, but not limited to, Merck websites and promotional materials related to the ZICL without permission from Participant. Except as expressly permitted above, any additional use of Participant’s name or any other use of Participant’s trademarks or other intellectual property shall require Participant’s prior written consent.

Representations and Warranties:

The person submitting the enrollment is agreeing to the following on behalf of the Participant included in the electronic application and is representing and warranting that he or she has authority to agree to the following on behalf of the Participant included in the electronic application:

a) Participant represents and warrants that (i) all of the information provided by Participant to be included in the ZICL is correct and current and each Participant location will comply with the ZICL eligibility requirements set forth herein; and (ii) Participant agrees to and shall comply with these Terms and Conditions.
b) Participant represents and warrants that it shall comply with all laws, statutes, and regulations that apply to its obligations hereunder.
c) Participant represents and warrants that it shall act in compliance with all federal, state, and local laws, regulations, and licensing requirements, including but not limited to those applicable to patient consent, licensing, testing, and privacy of medical records and medical information confidentiality.

Miscellaneous:

a) Choice of Law. These Terms and Conditions shall be governed by the laws of the Commonwealth of Pennsylvania, without giving effect to Pennsylvania’s choice of law or arbitration provisions, and the Federal and state courts therein shall have jurisdiction over the subject matter and the parties.
b) Mutual Undertakings. Merck and Participant understand and agree that the mutual undertakings provided for in the Terms and Conditions for the ZICL are good and sufficient consideration for each party’s obligations hereunder.
c) No Agency. Merck and Participant understand and agree that neither party is acting as an agent of the other and that neither party has the power to or shall act on behalf of or seek to bind the other party in any manner.
d) No Endorsement. Participant acknowledges and agrees that inclusion in the ZICL is not an endorsement, referral or recommendation of Participant by Merck

Adverse Events Reporting:

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Print the Terms and Conditions

CANCEL I AGREE

Step 2: Enter information to submit for possible inclusion in the ZINPLAVA Infusion Center Locator

Infusion Center Location Information

*Denotes required field

*Organization:

*Address – Line 1:

Address – Line 2:

*City:

*State:

*ZIP Code:

Website:

*Telephone:

Infusion Center Point of Contact for ZICL

Salutation:

*First Name: MI:

*Last Name:

Generational Suffix:

*Telephone:

*Email:

*Verify Email:

Interested in receiving ongoing emails from Merck? Please read the below and check the box if you would like these emails.

I agree that Merck, the companies with whom Merck collaborates to jointly offer products and services, and the companies working on their behalf may contact me via email regarding product information, special offers, educational opportunities, additional medical resources, programs, and information about Merck.

I understand that by providing the infusion center email, I am authorized to provide the consent to have emails about the above topics sent to this email address. I also understand that my request for emails from Merck does not in any way affect my enrollment into the ZINPLAVA Infusion Center Locator and does not obligate me to participate in the ZINPLAVA Infusion Center Locator.

CANCEL NEXT

Step 3: Enter License Information

Enter the number of infusion centers to enroll and click NEXT.

Step 4: Enter Additional License Information

Location Contact should be the administrator(s) at the practice.

Infusion Center License Number: State:

Please review your Location Information to ensure all information is correct.

Infusion Center Location Information (which if published, will be displayed in the ZICL)

Business Name:

., , ,

Phone: - - . Website: .

Associated Contact(s) Information (which will NOT be displayed in the ZICL)

Infusion Center Location:

Contact:

Phone: - - . Email Address:

Please Note: The information you submit will be reviewed by the ZINPLAVA Infusion Center Locator Processing Center. If needed, the Processing Center will try to contact you.

MODIFY SUBMIT

., , ,

Phone: - - . Website:

Infusion Center License Number:

Contact:

Phone: - - .

Before Confirming

Before you submit this location for consideration, please be sure to review all address information, as this is how the data will appear on the ZINPLAVA Infusion Center Locator (ZICL) if center is accepted. If you have any questions, please contact us at 1-855-637-2522.

By executing this Request for inclusion in the ZINPLAVA Infusion Center Locator, you represent and warrant that you have authority to request inclusion in the ZINPLAVA Infusion Center Locator (“ZICL”) on behalf of the infusion center identified in this electronic application and that you and the infusion center agree to the Terms and Conditions of the ZICL. By providing the Infusion Center's state license number, you and the Infusion Center consent to release it to Merck in order for Merck to administer the ZICL. (All notices and written communications relating to this Program shall be sent to the contact person named above.) Upon acceptance into the ZINPLAVA Infusion Center Locator, infusion center will become a Participant.

Inclusion of locations in this database does not represent an endorsement, referral, or recommendation from Merck.

By providing your information and signature above, Participant agrees that Merck, and its agents, together with the companies with whom Merck collaborates and their agents and companies working for them, may contact Participant/Participant's Point of Contact via e-mail or telephone regarding ZINPLAVA and the ZICL. The companies working for Merck have agreed to use this information only at the direction of Merck and also have agreed not to share this information with any third parties, except as required by law. Merck will not disclose personal information to anyone other than these companies, except as required by law.

If you have any questions regarding the above Terms and Conditions, please call 1-855-637-2522.

RETURN CONFIRM

A live representative is available to answer your questions at 800-235-1445 Monday – Friday 8 AM – 6 PM

Indication

ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Selected Safety Information for ZINPLAVA

In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.
The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy were nausea (7% vs 5%), pyrexia (5% vs 3%), and headache (4% vs 3%).
Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of placebo-treated patients.
In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.
As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of the incidence of antibodies to bezlotoxumab in the two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. In those 2 Phase 3 studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

Before prescribing ZINPLAVA™ (bezlotoxumab), please read the Prescribing Information. The Patient Information also is available.

Indication

ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Selected Safety Information for ZINPLAVA

In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated

In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.
The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy were nausea (7% vs 5%), pyrexia (5% vs 3%), and headache (4% vs 3%).
Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of placebo-treated patients.
In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.
As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of the incidence of antibodies to bezlotoxumab in the two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. In those 2 Phase 3 studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

Before prescribing ZINPLAVA™ (bezlotoxumab), please read the Prescribing Information. The Patient Information also is available.

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