Learn About Zejula Tablets

NEW ZEJULA TABLETS:

SAME MAINTENANCE TREATMENT, NEW DOSAGE FORM^1,2

NEW ZEJULA TABLETS:

SAME MAINTENANCE TREATMENT, NEW DOSAGE FORM^1,2

AVAILABLE NOW. YOUR PATIENTS SHOULD CONTINUE TAKING ZEJULA CAPSULES AS PRESCRIBED UNTIL YOU WRITE A NEW ZEJULA TABLETS PRESCRIPTION FOR THEM^1,2

One tablet, once daily, regardless of strength²
May reduce pill burden: patients will take 1 tablet at their prescribed dose compared to one or more capsules^1,2

Tablets are film coated and have a reduced^asize compared to capsules³

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^aBased on length.

Tablet ingredients:

Contain less lactose than capsules
Does not contain gelatin and tartrazine (a potential allergen)

Every patient needs a new prescription when switching from ZEJULA capsules to tablets

THE SAME CONVENIENT ONCE-DAILY DOSING – NOW IN TABLET FORM^1,2

^bImage of capsules and tablets are not actual size.

SEE THE NDC CODES BELOW FOR MORE INFORMATION.

ZEJULA tablets contain the same active ingredients with the same expected efficacy^1,2

ZEJULA tablets have been demonstrated to be bioequivalent and interchangeable^1-3c:

100 mg tablet has the same amount of niraparib as the 100 mg capsule
200 mg tablet has twice the amount of niraparib as the 100 mg capsules
300 mg tablet has three times the amount of niraparib as the 100 mg capsules
In a pharmacokinetic study, ZEJULA tablet formulation (300 mg) was shown to be bioequivalent to the marketed capsule formulation (3 x 100 mg)^3c

^cIn a pharmacokinetic study with 108 patients with solid tumors, under fasting conditions, one 300 mg tablet was bioequivalent to three 100 mg capsules, based on plasma concentration of niraparib.

NEW DOSAGE FORM, SAME TREATMENT SCHEDULE^1,2

Tablet can be taken at any time of day. Patients should take their dose at approximately the same time each day^d

^dBedtime administration may be a potential method for managing nausea.

Tablet should be swallowed whole, do not crush, chew, or split tablet

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ZEJULA may be taken with or without food

If a patient vomits or misses a dose, an additional dose should not be taken. The next dose should be taken at its regularly scheduled time.

No specific drug-drug interactions have been reported with ZEJULA.^e

^eNo clinical drug interaction studies have been performed with ZEJULA.

GIVE YOUR PATIENTS A TAILORED DOSE FROM THE START^f

^fFor patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed. For the maintenance therapy of patients with recurrent germline BRCA-mutated ovarian cancer, the recommended dosage is 300 mg/day.

HELP GUIDE YOUR PATIENTS THROUGH THE ZEJULA TABLETS TRANSITION WITH THE BROCHURE BELOW:

DOWNLOAD THE PATIENT
EDUCATIONAL BROCHURE

Your patients can expect:

ZEJULA tablets will be available in 3 different strengths: 300 mg, 200 mg, and 100 mg^2g
The recommended once-daily dosage of ZEJULA remains the same, regardless of the strength²

^g300 mg, 200 mg, and 100 mg tablets will have different colors, debossed strengths on one side, and “ZEJULA” on the other.

ZEJULA will now come in a round bottle.^h

^hTablets must be stored and dispensed in original bottle.

Planning for a smooth transition for your patients

Specialty distributors have begun shipping tablets exclusively
Pharmacies can continue to fulfill prescriptions for capsule formulation until stock runs out
New prescriptions will need to be written for ZEJULA tablets

No interruption to your patients’ therapy with ZEJULA should be needed due to change in formulation.

ZEJULA Free Trial and Dose Modification Program

Available for new patients or patients who require mid-cycle dose changes of their current tablet strength.

All ZEJULA prescriptions replaced through the program are filled through PharmaCord mail order pharmacy.

If future prescriptions are needed, they must be submitted to the patient’s designated specialty or in-office dispensing pharmacy and are subject to review and approval by the patient’s payer.

Future prescriptions are not required to participate in the ZEJULA Free Trial and Dose Modification Program.

The Free Trial and Dose Modification Program is available now. Please visit this link to enroll your eligible patients and see full terms and conditions.

In-person or Virtual Sample Ordering

Sample Programⁱ

Help your eligible patients get started on ZEJULA tablets

In-person or virtual sample ordering options are available, talk to your GSK representative^j,k or request a sample online on your own time by registering at www.gsksamples.com^l

Patients Can Save on ZEJULA

The ZEJULA Co-Pay Program helps eligible commercially insured patients with their out-of-pocket costs for ZEJULA up to $26,000 for 12 months. Eligibility for the ZEJULA Co-Pay Program must be determined by the GSK Co-Pay Program. Eligibility restrictions and program maximums apply. Visit www.togetherwithgskoncology.com for complete Program Terms and Conditions.

One source for GSK access and reimbursement services

ⁱSamples are only for new patients to assess ZEJULA for tolerability. Before providing a patient with samples, first do a health benefit check to assess their prescription coverage. If patient assistance is required, samples are not appropriate. This will help ensure continued coverage or determine if patient assistance is required. All healthcare providers are eligible to receive saving offers, but not all are eligible to receive ZEJULA samples. A sample order for a patient should not exceed two 30-count bottles of ZEJULA 200 mg or 300 mg tablets. Samples are not for sale, trade, or reimbursement; therefore, samples cannot be billed or resold.

^jA remote signature through Veeva by the licensed healthcare provider is required before the meeting with a GSK representative ends. Once the signature is obtained, sample orders cannot be changed or cancelled. The signed sample request is restricted to only ZEJULA samples; any promotional material items are not available.

^kSample Request Forms can now be completed electronically via QSign. Completed Sample Request Forms need to be signed and dated. Once an order is submitted, it cannot be cancelled.

^lZEJULA Samples Program on GSKPro limits quantities from all sources to a total of 4 orders of 1 bottle per quarter.

THE SAME CONVENIENT ONCE-DAILY DOSING, NOW IN TABLET FORM^1,2

Indication

Important Safety Information

Indication and Important Safety Info

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with a fatal outcome, have been reported in patients who received ZEJULA. In PRIMA, MDS/AML occurred in 6 out of 484 (1.2%) patients treated with ZEJULA, and in 3 out of 244 (1.2%) patients treated with placebo. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy-related AML varied from 3.7 months to 2.5 years. All patients who developed secondary MDS/cancer therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

Important Safety Information

Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations.

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose if necessary.

Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Monitor all patients for signs and symptoms of PRES, which include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension. Diagnosis requires confirmation by brain imaging. If suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown.

Embryo-fetal toxicity and lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women not to breastfeed during treatment with ZEJULA and for 1 month after receiving the last dose.

Allergic reactions to FD&C Yellow No. 5 (tartrazine): ZEJULA capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

First-line Maintenance Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (64%), nausea (57%), fatigue (51%), neutropenia (42%), constipation (40%), musculoskeletal pain (39%), leukopenia (28%), headache (26%), insomnia (25%), vomiting (22%), dyspnea (22%), decreased appetite (19%), dizziness (19%), cough (18%), hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%).

Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (87%), decreased platelets (74%), decreased leukocytes (71%), increased glucose (66%), decreased neutrophils (66%), decreased lymphocytes (51%), increased alkaline phosphatase (46%), increased creatinine (40%), decreased magnesium (36%), increased AST (35%), and increased ALT (29%).

Please see accompanying Prescribing Information for ZEJULA capsules and tablets.

References: 1. ZEJULA capsules (niraparib). Prescribing Information. GSK; 2023. 2. ZEJULA tablets (niraparib). Prescribing Information. GSK; 2023. 3. Data on file, GSK.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If your patients need help paying for their medicines or to learn about other patient access and reimbursement services, visit TogetherWithGSKOncology.com or call 1-844-4-GSK-ONC (1-844-447-5662)

Trademarks are owned by or licensed to the GSK group of companies.

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ZEJULA tablets contain the same active ingredients with the same expected efficacy1,2

Planning for a smooth transition for your patients

ZEJULA Free Trial and Dose Modification Program

Available for new patients or patients who require mid-cycle dose changes of their current tablet strength.

In-person or Virtual Sample Ordering

Sample Programi

Help your eligible patients get started on ZEJULA tablets

Patients Can Save on ZEJULA

ZEJULA tablets contain the same active ingredients with the same expected efficacy^1,2

Sample Programⁱ