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DEXAPOMA

Cancer Type: Hematologic, Multiple Myeloma  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
Exceptional Access Program
    pomalidomide - For patients with relapsed and/or refractory multiple myeloma, according to specific criteria.
ODB - General Benefit
    dexamethasone
A - Regimen Name

DEXAPOMA Regimen
Dexamethasone-Pomalidomide


Disease Site
Hematologic - Multiple Myeloma

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

In combination with dexamethasone for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen.

 


Supplementary Public Funding

pomalidomide
Exceptional Access Program (pomalidomide - For patients with relapsed and/or refractory multiple myeloma, according to specific criteria.) (EAP Website)

dexamethasone
ODB - General Benefit (dexamethasone)

 
B - Drug Regimen

pomalidomide
4 mg PO daily Days 1 to 21

(Outpatient prescription in 1 mg, 2 mg, 3 mg or 4 mg capsules)

Pomalidomide may only be prescribed and dispensed by physicians and pharmacists registered with RevAid®. Patients must also be registered and meet all conditions of the RevAid® program.

dexamethasone
20 to 40* mg PO Days 1 ,8, 15 and 22

*Decrease dexamethasone dose to 20 mg in patients > 75 years old

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C - Cycle Frequency

REPEAT EVERY 28 DAYS

Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal – No routine prophylaxis; PRN recommended

Other Supportive Care:

Prophylatic antithrombotics, such as low dose aspirin, low molecular weight heparins or warfarin is recommended.

Patients at risk of tumour lysis syndrome should have appropriate prophylaxis and be monitored closely.

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

Women of child bearing potential must have two negative pregnancy tests before initiating treatment. 

Start treatment only if ANC ≥ 1 x 109/L and platelets ≥ 50 x 109/L.

Dose levels:

Dose Level

Dose (days 1-21; q28 days)

Initial Dose

4 mg

First Reduction

3 mg

Second Reduction

2 mg

Third Reduction

1 mg

Further reduction required

Discontinue

Dosage with toxicity

Toxicity

 
 

Dose of pomalidomide*

Dose of dexamethasone

ANC (109/L) < 0.5 or Febrile neutropenia (fever ≥38.50C and ANC < 1)

 
or

Platelets (109/L)< 25

Hold, monitor CBC weekly, consider G-CSF. Restart* after recovery with 1 dose level ↓

 
 
n/a
Grade 2 or 3 skin rash     Hold or discontinue. Resume if benefit outweighs potential risk.

n/a

Grade 4 rash or rash with exfoliation, bullae or purpura, Angioedema or suspected SJS/ TEN/ DRESS

   

 

Discontinue

 

Discontinue

Grade 3 or 4 non-hematologic/organ toxicities

 
 

Hold until recovery then ↓ 1 dose level. Consider discontinuing if grade 4

 
 
n/a
Infection in patients aged 66-75
 
 
 
Consider hold or reduction

Acute onset or worsening of pulmonary symptoms

   

Hold and investigate for pneumonitis. Resume only after an evaluation of the benefits and risks.

 

n/a

*Do not re-start until ANC returns to ≥ 1 x 109/L and platelets ≥ 50 x 109/L, and non-hematological toxicities resolve to ≤grade 2



Hepatic Impairment

Pomalidomide is primarily metabolized in the liver and its use should be avoided in patients with grade 2 or higher elevations in bilirubin and transaminases. Hepatic impairment results in a 51-72% increase in drug exposure. The starting dose should be adjusted as follows:

 

Hepatic impairment Pomalidomide dose
Child-Pugh class A or B 3 mg daily
Child-Pugh class C 2 mg daily

 


Renal Impairment

Pomalidomide and its metabolites are renally excreted and are dialyzable. The starting dose should be adjusted for severe impairment as follows:

Creatinine Clearance (mL/min) Pomalidomide dose
< 30 requiring dialysis 3 mg daily taken after dialysis

 

 


Dosage in the Elderly

No dose adjustment required.  No overall differences in effectiveness were observed.  Patients > 65 years were observed to have higher incidences of infection and pneumonia than younger patients; dexamethasone holds or reductions may be required.  There is limited information in patients over 75 years old.  Dose of dexamethasone should be reduced by 50% in patients > 75 years (dexamethasone 20mg days 1, 8, 15, 22; q28d).

 


 
F - Adverse Effects

Refer to pomalidomide, dexamethasone drug monograph(s) for additional details of adverse effects.


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Myelosuppression +/- infection (including atypical, viral reactivation), bleeding (may be severe)
  • Fatigue
  • Constipation
  • Diarrhea
  • Cough, dyspnea (may be severe)
  • Musculoskeletal pain
  • Edema
  • Proteinuria
  • Nausea, vomiting
  • Peripheral neuropathy
  • Anorexia
  • Abnormal electrolytes
  • Cardiotoxicity
  • Atrial fibrillation
  • Venous thromboembolism
  • Hypersensitivity
  • SJS/ TEN
  • DRESS
  • Renal failure
  • Tumour lysis syndrome
  • Secondary malignancy (non-melanoma skin cancer)
  • Increased LFTs
  • Pneumonitis
 
G - Interactions

Refer to pomalidomide, dexamethasone drug monograph(s) for additional details


  • Pomalidomide is a substrate for CYP3A4 and CYP1A2 and is susceptible to interactions with inhibitors/inducers of these enzymes.
  • Avoid strong inhibitors of CYP1A2 if possible. If not possible to avoid, reduced the pomalidomide dose by 50%.
  • Pomalidomide increases thromboembolic and would have an additive effect if coadministrated with other thromboembolic agents
  • Pomalidomide has an additive effect when given with other CNS depressants.
 
H - Drug Administration and Special Precautions

Refer to pomalidomide, dexamethasone drug monograph(s) for additional details


Administration:

  • Swallow capsule whole with a glass of water. Do not crush or open.
  • Doses may be administered with or without food.
  • Missed dose: If less than 12 hours has passed since the missed dose, the dose may be taken. If more than 12 hours has passed since the missed dose, skip this dose and take the next one at its usual time the next day. Do not give a double dose to make up for a missed one.
  • Store at room temperature (15-30°C) in original package in order to protect from light.
  • Females who could become pregnant or who plan to become pregnant can handle pomalidomide capsules if they are using latex gloves.
  • Drug available by outpatient prescription in pharmacy registered with the RevAid® program. Please call 1-888-RevAid-1 or log onto www.RevAid.ca

Contraindications:

  • Patients who have a hypersensitivity to this drug, any of its components, or to thalidomide or lenalidomide
  • Patients who are pregnant, at risk of becoming pregnant, or are breastfeeding (see “pregnancy and lactation” section)
  • Male patients unable to comply with required contraceptive measures
  • Patients with moderate to severe hepatic impairment (bilirubin and AST/ALT ≥ grade 2)

Warnings/precautions:

  • Use with caution and consider prophylaxis when used in combination with corticosteroids or thrombogenic agents, such as hormones and erythropoietin or in patients with risk factors for arterial or venous thromboembolism (e.g. hypertension, hyperlipidemia, previous history of thromboembolism, or taking other agents that increase thromboembolic risk.  Prophylaxis with aspirin, LMWH or warfarin is recommended.
  • Caution in patients with pre-existing ≥ grade 2 neuropathy or significant cardiac dysfunction (e.g. MI within 12 months, unstable or poorly controlled angina, etc.) as pomalidomide use has not been studied in these patients.
  • Avoid use in patients with active / history of hepatitis A, B, or C
  • Avoid use in patients taking other immunosuppressive treatments, to reduce the risk of developing serious infections.
  • Patients should not donate blood or semen while taking pomalidomide, during treatment interruptions, and for 4 weeks after stopping therapy.

Pregnancy and lactation:

Pomalidomide is contraindicated in pregnancy and breastfeeding, and in males and females of childbearing potential who do not comply with the contraception conditions of the RevAid® program. Females of childbearing potential (all women who are not ≥ 2 years menopausal OR have not had hysterectomy or bilateral oophorectomy) must be capable of understanding and complying with the patient registration, education, and safety requirements of the RevAid® program, regular pregnancy testing and the use of two simultaneous contraception methods (must be started at least one month prior to starting treatment, continued during dose interruptions, during treatment and for at least 1 month following the cessation of pomalidomide). SEE FULL DETAILS ON THE REVAID® PROGRAM. Hormonal contraceptives are not recommended due to the increased risk of thromboembolism. If pregnancy occurs during treatment, pomalidomide must be discontinued and patient referred to a gynecologist/obstetrician for evaluation and counseling.

Male patients must be capable of understanding and complying with the patient registration, education, and safety requirements of the RevAid®, including mandatory contraceptive measures for men (condoms should be used even with vasectomized males) as pomalidomide is present in semen and exposure would harm a developing fetus.   Male patients should not donate semen while taking pomalidomide, during treatment interruptions, and for 4 weeks after treatment cessation. 

 
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, weekly for the first 8 weeks then monthly thereafter
  • Liver function tests; Baseline and at each visit
  • Renal function tests; Baseline and at each visit
  • RevAid requirements regarding pregnancy tests for women of child-bearing potential; Before starting, during treatment and for at least 1 month after discontinuation
  • Hepatitis serology; if hepatitis or reactivation is suspected
  • Clinical toxicity assessment for infection, bleeding, hypersensitivity, rash, thromboembolism, secondary malignancies, neuropathy, pulmonary symptoms, hepatitis, TLS; 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

Pomalidomide drug monograph, Cancer Care Ontario.

San Miguel J et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM- 003): a randomized, open-label, phase 3 trial. Lancet Oncol 2013;14:1055-66.

 


May 2019 Updated emetic risk category; added PEBC guideline link


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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.
While care has been taken in the preparation of the information contained in the Formulary, 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.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.