IMPORTANT PRESCRIBING INFORMATION UPDATE DEC 2022

IMPORTANT PRESCRIBING INFORMATION UPDATE JUN 2022

This site is intended for US healthcare professionals only.

RUBRACA is a PARP inhibitor (PARPi) approved to treat and benefit patients with certain tumor types

pharmaand GmbH (pharma&), owners of RUBRACA^® (rucaparib) tablets, recognizes the importance of starting/continuing eligible patients’ treatment with RUBRACA and provides seamless access to all our products. We ensure uninterrupted product supply to healthcare professionals and patients, and all strengths of RUBRACA will remain available in the United States.

For prostate cancer patients

RUBRACA is the ONLY PARPi that can be used as a monotherapy following ANY androgen receptor-directed therapy and a taxane-based chemotherapy^1-4*

RUBRACA for BRCAmut+ mCRPC

Promoted in the US exclusively by Tolmar for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

^*Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

For ovarian cancer patients

For patients with BRCAmut+ ovarian cancer, RUBRACA can be used as a maintenance treatment when their cancer has come back and they are responding (complete or partial response) to a platinum-based chemotherapy¹

RUBRACA for recurrent BRCAmut+ ovarian cancer maintenance

pharma& will continue to promote RUBRACA in the US and Europe in approved indications for advanced ovarian cancer.

Support programs are available for RUBRACA

QuickStart Program^†

Helps patients start RUBRACA if they experience coverage delays regardless of income or insurance. Eligible patients receive a 15-day supply of RUBRACA for up to 60 days (2 months) while coverage is pending or until alternate funding resources have been identified and approved.

Coverage Link Program^†

Provides a free supply of RUBRACA in 15-day increments (up to 90 days) for eligible patients who experience a change in commercial insurance status, which includes changing to a new insurer following a job change or switching plans during an employer’s annual enrollment period.

RUBRACA Co-Pay Assistance Program^†

As little as $0 co-pay program for eligible patients with private or commercial insurance who are prescribed RUBRACA.

Patient Assistance Program (PAP)^†

Available for eligible patients who are uninsured or cannot afford medication.

^†Terms & Conditions may apply.

The RUBRACA Enrollment and Comprehensive Support Form can help with access to RUBRACA.

Help document your patient’s medical need for treatment to gain coverage with the RUBRACA Letter of Medical Necessity.

VIEW THE FULL TERMS & CONDITIONS FOR THE ACCESS PROGRAMS

TERMS & CONDITIONS FOR THE pharma& QUICKSTART PROGRAM 

Eligibility Criteria

RUBRACA (rucaparib) must be prescribed on-label by an appropriately licensed health care professional (HCP), and the HCP must certify that based on his/her independent medical judgment, RUBRACA is a medically appropriate treatment option for the patient
Patient must have either commercial or government insurance
Patient must reside in the US or US Territories and be 18 years old or older
Patient must be new to RUBRACA treatment – existing RUBRACA patients are not eligible
Patient must request a coverage determination from their insurer and must experience a coverage delay of more than 5 days

Terms & Conditions

Patient may be eligible for free RUBRACA for up to 60 days of therapy. Quick Start product will end the earlier of (1) the patient receiving a coverage determination, or (2) 60 days
Not available to uninsured patients
Patients and participating prescribers agree not to seek reimbursement for all, or any, part of the benefit
Product will be shipped approximately every 15 days
Patients are eligible for Quick Start once per lifetime
This program is not health insurance. This program may not be combined with any other financial assistance program, free trial, discount, rebate, coupon, or other offer
pharma& reserves the right to make eligibility determinations and to rescind, revoke, or amend the program and discontinue support at any time without notice

TERMS & CONDITIONS FOR THE pharma& COVERAGE LINK BRIDGE PROGRAM

Eligibility Criteria

RUBRACA (rucaparib) must be prescribed on-label by an appropriately licensed health care professional (HCP), and the HCP must certify that based on his/her independent medical judgment, RUBRACA is a medically appropriate treatment option for the patient
Patient must have either commercial or government insurance
Patient must reside in the US or US Territories and be 18 years old or older
Patient must be an existing RUBRACA patient who has had a change in insurance and is experiencing a delay in obtaining insurance coverage from their new insurer
Patient must request a coverage determination from their new insurer and must experience a coverage delay of more than 5 days

Terms & Conditions

Patient may be eligible for free RUBRACA for up to 60 days of therapy. Coverage Link product will end the earlier of (1) the patient receiving a coverage determination, or (2) 60 days
Not available to uninsured patients
Patients and participating prescribers agree not to seek reimbursement for all, or any, part of the benefit
Product will be shipped approximately every 15 days
This program is not health insurance. This program may not be combined with any other financial assistance program, free trial, discount, rebate, coupon, or other offer
pharma& reserves the right to make eligibility determinations and to rescind, revoke, or amend the program and discontinue support at any time without notice

TERMS & CONDITIONS FOR THE pharma& CO-PAY PROGRAM

Patient Instructions

If you are an eligible, commercially insured patient, the RUBRACA co-pay card will reduce your out-of-pocket costs up to the copay program annual limitation. If you reach the maximum annual limit, you will be responsible for any additional cost.

When you use this card, you are certifying that you understand and agree to comply with the program Terms & Conditions below.

Terms & Conditions

This offer is only available to patients with commercial insurance. The program is not available for patients who receive reimbursement under any federal, state or government-funded insurance programs, including patients who: (i) are enrolled in Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program; (ii) are not using insurance coverage at all; (iii) are enrolled in an insurance plan that reimburses for the entire cost of the drug; or (iv) where product is not covered by patient’s insurance
The value of this program is exclusively for the benefit of patients and is intended to be credited toward patient out-of-pocket obligations, including applicable copayments, coinsurance, and deductibles
Co-pay maximizers are programs in which the amount of your out-of-pocket costs is increased to reflect the availability of support offered by a manufacturer assistance program. Except where prohibited by applicable state law, if your insurance company or health plan implements either an accumulator adjustment or co-pay maximizer program, you will not be eligible for, and agree not to use, co-pay assistance because these programs are inconsistent with our agreed intent that this program is solely for your benefit. You also agree that you are personally responsible for paying any amount of co-pay required after the savings card is applied. Any out-of-pocket costs remaining after the application of the savings card may not be paid by your health plan, pharmacy benefit programs, or any other program
If you learn your insurance company or health plan has implemented either an accumulator adjustment program or a co-pay maximizer program, you agree to inform pharma& of this fact by calling 1-844-779-7707 to discuss alternative options that may be available to support you. Since you may be unaware whether you are subject to a co-pay maximizer program when you enroll in the copay assistance program, Pharma& will monitor program utilization data and reserves the right to discontinue co-pay assistance at any time if pharma& determines that you are subject to a co-pay maximizer program. If your health plan removes RUBRACA from a co-pay maximizer program, you will return to eligibility for co-pay assistance up to the maximum annual benefit
Proof of purchase may be required
Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account
Patient is responsible for complying with any applicable limitations and requirements of his/her health plan related to the use of the program. The program may not be used if prohibited by a patient’s health insurer
Program is not valid where prohibited by law. Valid only in the United States and US Territories: American Samoa, Guam, Northern Mariana Island, Puerto Rico and US Virgin Islands
This program is not health insurance. This program may not be combined with any other financial assistance program, free trial, discount, rebate, coupon, or other offer
pharma& reserves the right to make eligibility determinations and to rescind, revoke, or amend the program and discontinue support at any time without notice
For complete information about the terms & conditions of this program, including the limitations on use and the amount of assistance, call 844-779-7707

TERMS & CONDITIONS FOR THE pharma& PATIENT ASSISTANCE PROGRAM

Eligibility Criteria

RUBRACA (rucaparib) must be prescribed on-label by an appropriately licensed health care professional (HCP), and the HCP must certify that based on his/her independent medical judgment, RUBRACA is a medically appropriate treatment option for the patient
Patient must be either uninsured or insured without coverage for RUBRACA after completing any available appeals process
Patient must reside in the US or US Territories and be 18 years old or older
Patient must have gross annual household income at or below 300% of the current Federal Poverty Level (FPL) (FPL Guidelines available at https://aspe.hhs.gov/poverty-guidelines). Below are the 300% 2024 FPL limits based on household size:

Household Size	Annual Income*
1	$45,180 or less
2	$61,320 or less
3	$77,460 or less
4	$93,600 or less
If your household has more than four members, please add $16,140* for each additional dependent member.

^*Subject to change in 2025, as the FPL is updated annually by the U.S. government.

Terms & Conditions

Patient may be asked to submit documentation (e.g., federal tax returns; IRS forms such as W-2, 1099, 4506T; Social Security statement/checks/benefit letter; pension or disability benefit statement/letter; unemployment compensation statement; pay stubs) to validate levels of income
pharma& will review all submitted documentation, including the pharma& Patient Assistance Program eligibility form and all substantiating information, prior to approving a patient for eligibility under the pharma& Patient Assistance Program
Both the patient and prescriber must sign and date all submitted documentation to attest to the accuracy of the information
Uninsured patients, commercially insured patients, and federal healthcare program beneficiaries who qualify for the pharma& Patient Assistance Program are enrolled for the entire calendar year. However, pharma& reserves the right to reassess eligibility for uninsured patients and patients with commercial insurance during the calendar year
The pharma& Patient Assistance Program is not insurance
Provision of free product under this program is not contingent upon future purchase or prescribing of RUBRACA
No patient, pharmacy, payer, or other third party may be billed for the free product provided through the pharma& Patient Assistance Program.
Patients and providers agree not to submit any claims for reimbursement for all or any part of the free product provided through the pharma& Patient Assistance Program. If the HCP or pharmacy receives any payments for products provided under this program, they agree to return such payments to the applicable payer or patient
Patient, pharmacist, and prescriber agree to not sell, purchase, trade, or offer to sell, purchase, or trade any free product received through the pharma& Patient Assistance Program
Patient cannot apply the value of the free product received through the pharma& Patient Assistance Program toward any insurance benefit out-of-pocket spending calculations
pharma& retains the right to make the final decision regarding any pharma& Patient Assistance Program product request. All product requests are subject to review at pharma&’s sole discretion, and all decisions by pharma& are final
pharma& requires that you re-apply every year
pharma& reserves the right to modify or revoke this program at any time without notice

These Terms & Conditions are effective as of 01/01/2025.

BRCA, BReast CAncer gene; BRCAmut+, BRCA mutation positive, including mutations in the BRCA1 and/or BRCA2 gene; PARP, poly (adenosine diphosphate-ribose) polymerase.

REFERENCES: 1. RUBRACA (rucaparib). Prescribing Information. pharma& Schweiz GmbH. 2023. 2. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP. 2023. 3. Akeega (talazoparib). Prescribing Information. Janssen Biotech, Inc. 2023. 4. Talzenna (talazoparib). Prescribing Information. Pfizer Inc. 2024

Tap for safety information

INDICATIONS

RUBRACA is indicated:

for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients (2%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.9%). The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents. In ARIEL3, of patients with a germline and/or somatic BRCA mutation treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue RUBRACA.

RUBRACA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of RUBRACA.

For males on RUBRACA treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of RUBRACA. Advise male patients on RUBRACA treatment, who have female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of RUBRACA.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (79%), fatigue/asthenia (74%), abdominal pain/distention (48%), rash (45%), dysgeusia (33%), anemia (41%), AST/ALT elevation (33%), constipation (39%), vomiting (37%), diarrhea (34%), thrombocytopenia (35%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (22%).

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions decrease the substrate dosage in accordance with the approved prescribing information. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from RUBRACA, advise lactating women not to breastfeed during treatment with RUBRACA and for 2 weeks after the last dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to pharma& at 1-800-506-8501.

Please see full Prescribing Information for RUBRACA.

IMPORTANT: The information on this website is based on the US prescribing information (US PI).

RUBRACA is a PARP inhibitor (PARPi) approved to treat and benefit patients with certain tumor types

For prostate cancer patients

RUBRACA for BRCAmut+ mCRPC

For ovarian cancer patients

RUBRACA for recurrent BRCAmut+ ovarian cancer maintenance

Support programs are available for RUBRACA

QuickStart Program†

Coverage Link Program†

RUBRACA Co-Pay Assistance Program†

Patient Assistance Program (PAP)†

TERMS & CONDITIONS FOR THE pharma& QUICKSTART PROGRAM

TERMS & CONDITIONS FOR THE pharma& COVERAGE LINK BRIDGE PROGRAM

TERMS & CONDITIONS FOR THE pharma& CO-PAY PROGRAM

TERMS & CONDITIONS FOR THE pharma& PATIENT ASSISTANCE PROGRAM

INDICATIONS

RUBRACA is indicated:

SELECT IMPORTANT SAFETY INFORMATION

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QuickStart Program^†

Coverage Link Program^†

RUBRACA Co-Pay Assistance Program^†

Patient Assistance Program (PAP)^†

TERMS & CONDITIONS FOR THE pharma& QUICKSTART PROGRAM 