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OLAP - capsule

Cancer Type: Gynecologic, Ovary  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
Exceptional Access Program
    Platinum-sensitive, relapsed, BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer, with specific criteria
A - Regimen Name

OLAP - capsule Regimen
olaparib
(CAPSULE)


Disease Site
Gynecologic - Ovary

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

For the maintenance treatment of adult patients with platinum-sensitive, relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial response) to platinum-based chemotherapy. Platinum sensitivity is defined as disease progressing at least 6 months after completion of the platinum-based chemotherapy.

 


Supplementary Public Funding

olaparib (capsule)
Exceptional Access Program (Platinum-sensitive, relapsed, BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer, with specific criteria) (EAP Website)

 
B - Drug Regimen

NOTE: Risk of Medication Error: Olaparib capsules and tablets are not interchangeable.

 

olaparib (capsule)
400 mg PO BID

(available as 50 mg capsules from a controlled distribution program)

Note: Olaparib capsules are only supplied through a controlled distribution program due to the differences in dosing and bioavailability between formulations. Capsules are only available for existing patients already using this dosage form; patients should be enrolled in the AstraZeneca Oncology Patient Support Program to continue to receive capsules.

 
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C - Cycle Frequency

CONTINUOUS TREATMENT

Until disease progression or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low – No routine prophylaxis; PRN recommended

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

NOTE:  The dose modifications below are applicable to the capsule formulation only.

Treatment should start no later than 8 weeks after completion of platinum-containing chemotherapy. Patients should have recovered from prior hematologic toxicities before starting olaparib (Hgb, ANC, platelets ≤ grade 1).

Patients should have confirmation of germline or somatic BRCA mutation status using a validated test before starting treatment.

Dosage with toxicity

Dose level Olaparib (CAPSULE) dose
0 400 mg BID
-1 200 mg BID
-2 100 mg BID
-3 discontinue

 

Toxicity Severity Action
Hematologic ≥ Grade 3 or blood transfusion dependence

Hold up to 4 weeks* and monitor CBC.

Restart at the same dose level once resolved.

Pneumonitis Any grade

Hold and investigate.

If confirmed, discontinue and treat appropriately.

MDS, AML or other clonal disorders  

Hold and investigate.

If confirmed, discontinue and treat appropriately.

Other non-hematologic Grade 3 or 4

Hold up to 4 weeks**

Upon recovery, consider dose reduction.

*Hold until ≤ grade 1. If blood parameters remain abnormal after 4 weeks, bone marrow analysis and/or blood cytogenetic analysis are recommended.
**Hold until ≤ grade 1. If toxicity recurs, reduce an additional dose level. Discontinue if more than 2 dose reductions are required.

 



Hepatic Impairment

Liver function Olaparib (CAPSULE) dose
Child Pugh A no change
Child Pugh B or C not recommended (not studied)

Renal Impairment

Creatinine clearance (ml/min) Olaparib (CAPSULE) dose

> 50

no change
31-50 300 mg bid
≤ 30 or end-stage renal disease not recommended (limited data)

Dosage in the Elderly

Although there is limited data in patients aged 65 and older, dosage adjustment is not required.

 


 
F - Adverse Effects

Refer to olaparib (capsule) drug monograph(s) for additional details


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Nausea, vomiting
  • Fatigue
  • Creatinine increased
  • Diarrhea
  • Dysgeusia
  • Headache
  • Anorexia
  • Myelosuppression +/- infection, bleeding (severe)
  • Cough
  • Dizziness
  • Dyspepsia
  • Mucositis
  • Secondary malignancies (MDS, AML)
  • Pneumonitis
  • Hypersensitivity
 
G - Interactions

Refer to olaparib (capsule) drug monograph(s) for additional details


  • Olaparib is primarily metabolised by CYP3A and is susceptible to inhibitors and inducers of this isoenzyme. Avoid moderate and strong CYP3A inducers and inhibitors during treatment. If the combination with inhibitors cannot be avoided, the dose of olaparib capsules should be reduced to 150 mg bid (strong) or 200 mg bid (moderate).
  • Co-administration with myelosuppressive agents should be avoided due to potentiation and prolongation of myelosuppression.
  • Olaparib may reduce the effectiveness of hormonal contraceptives. Consider an alternative (e.g. barrier) method of contraception.
  • The drug also inhibits CYP3A4 and induces CYP2B6 and is an inhibitor of several transporter proteins. See the olaparib drug monograph for details.
  • Administration with a high-fat meal increases absorption of capsules.
 
H - Drug Administration and Special Precautions

Refer to olaparib (capsule) drug monograph(s) for additional details.

Olaparib capsules and tablets are not interchangeable. Ensure the dosage and formulation are indicated clearly on the prescription.

Note: Olaparib capsules are only supplied through a controlled distribution program due to the differences in dosing and bioavailability between formulations. Capsules are only available for existing patients already using this dosage form; patients should be enrolled in the AstraZeneca Oncology Patient Support Program to continue to receive capsules.


Administration:

  • Olaparib capsules should be administered on an empty stomach (at least 1 hour after a meal) and patients should refrain from eating for up to 2 hours
  • Capsules should be swallowed whole and not chewed, crushed, dissolved or divided
  • Avoid grapefruit, starfruit, pomegranate, Seville oranges, their juices or products during treatment
  • If a dose is missed, the next dose should be taken at the regular scheduled time. A double dose should not be taken to make up for forgotten capsules.
  • Olaparib should be stored between 2 to 25oC
     

Contraindications/Precautions:

 

  • Patients who have a hypersensitivity to this drug or any of its components
  • Co-administration with other myelosuppressive agents.
     

 

Other Warnings/Precautions:

  • Olaparib capsules and tablets are not interchangeable; specify formulation and dosing on each prescription to prevent medication error
  • Use with caution in patients who have received prior DNA damaging agents. MDS and AML have been reported.
  • Use with caution in patients with lung cancer or metastases to the lungs, underlying pulmonary disease, smoking history and/or previous chemotherapy and radiotherapy as these patients are at increased risk of pneumonitis.

Pregnancy and lactation:

  • Olaparib is not recommended for use in pregnancy.  Adequate contraception should be used by women of child-bearing potential during treatment, and for at least one month after the last dose.
  • Olaparib may reduce the effectiveness of hormonal contraceptives. Consider an alternative (e.g. barrier) method of contraception.
  • A pregnancy test should be performed on all pre-menopausal women prior to treatment, regularly during treatment and one month after receiving the last dose.
  • Breastfeeding is not recommended during treatment and for one month after the last dose.
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

 

Recommended Clinical Monitoring

  • CBC; Baseline and monthly for the first 12 months; periodically thereafter
  • Pregnancy test; Before starting treatment in all pre-menopausal women of child-bearing potential, regularly during treatment and one month after the last dose
  • Clinical toxicity assessment for nausea and other GI effects, fatigue, anemia, MDS, infection, bleeding and respiratory effects; At each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Outpatient prescription for home administration


 
K - References

Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61.

Olaparib (capsule) drug monograph, Cancer Care Ontario.


PEBC Advice Documents or Guidelines

June 2019 Updated emetic risk category


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
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