Access and Patient Support

AstraZeneca support and resources designed to increase patient accessibility

At AstraZeneca, we don't want cost to be a factor. That’s why our goal is for eligible commercially insured patients to pay $0 per prescription for LYNPARZA through oncology savings programs.

$0 monthly copay target for eligible patients

the monthly co-pay target AstraZeneca strives to achieve for all eligible patients1,*

Nearly 99% of all LYNPARZA prescriptions were approved for reimbursement

of all LYNPARZA prescriptions with a known reimbursement status were approved for reimbursement2,†,‡

*The average monthly cost for LYNPARZA may be greater than $0 for some patients.1

Total prescriptions n=1658; prescriptions with unknown reimbursement status n=412.2

Reimbursement accounts for on-label use.2

LYNPARZA is distributed through specialty pharmacies that offer patients direct access to trained oncology nurses and pharmacists who can help with questions about treatment.

Helping patients access the care they need

The AstraZeneca Access 360™ program provides personal support to connect patients to affordability programs and streamline access and reimbursement for LYNPARZA. Access 360 provides:

  • Assistance with understanding patient insurance coverage and pharmacy options
  • Prior authorization support
  • Claims and appeal process support
  • Eligibility requirements and enrollment assistance for specialty Patient Savings Programs
  • Referrals to patient assistance programs
  • Referrals to nurse assistance or educational support programs, if applicable

To learn more about the AstraZeneca Access 360™ program, call 1-844-ASK-A360 (1-844-275-2360) Monday–Friday, 8 AM–8 PM ET, to speak with a knowledgeable member of our team or visit our Web site at www.MyAccess360.com.

This description of the AstraZeneca Access 360 program is for informational purposes only. AstraZeneca Access 360 does not file claims or appeals on behalf of health care professionals or patients and makes no representation or guarantee concerning reimbursement or coverage for any service or item. Information provided through the AstraZeneca Access 360 program does not constitute medical or legal advice and is not intended to be a substitute for a consultation with a licensed health care provider, legal counsel, or applicable third-party payer(s). AstraZeneca reserves the right to modify the AstraZeneca Access 360 program at any time without notice.

AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.

AstraZeneca Access 360 does not guarantee reimbursement.

My LYNPARZA Support Program

My LYNPARZA

A free support program providing patients with educational materials about their disease and treatment via regular communications. All patients enrolled in My LYNPARZA receive a Starter Kit with the following:

  • Pill organizer case
  • Daily and weekly pill organizers
  • Instruction sheet
  • 4 brochures: 1 for patients, 1 for caregivers, 1 for treatment tips, and 1 providing dosing information

Other LYNPARZA services at 1-800-770-8337 include:

LYNPARZA patient access assistance

PATIENT ACCESS ASSISTANCE

Patient access and reimbursement assistance from trained specialists

LYNPARZA financial support

FINANCIAL SUPPORT

LYNPARZA affordability through assistance with co-pays and out-of-pocket costs

How to order LYNPARZA tablets

HOW TO ORDER LYNPARZA TABLETS

Information about ordering LYNPARZA tablets through specialty pharmacies and distributors

LYNPARZA treatment support

PERSONALIZED TREATMENT SUPPORT

Access to trained oncology nurses and pharmacists who can help patients with questions about LYNPARZA treatment

 

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

  • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy

  • For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

ADVERSE REACTIONS—Maintenance Setting

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), and decreased appetite (21%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Advanced gBRCAm ovarian cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue (including asthenia) (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), increase in mean corpuscular volume (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If a strong or moderate CYP3A inhibitor must be co-administered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers when using LYNPARZA. If a moderate inducer cannot be avoided, there is a potential for decreased efficacy of LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild hepatic impairment (Child-Pugh classification A). There are no data in patients with moderate or severe hepatic impairment.

Renal Impairment: No adjustment to the starting dose is necessary in patients with mild renal impairment (CLcr=51-80 mL/min). In patients with moderate renal impairment (CLcr=31-50 mL/min), reduce the dose to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

Please see complete Prescribing Information, including Patient Information (Medication Guide).

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