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A - Regimen Name

IFNA(IND-MNT(SC)) Regimen
Interferon alfa-2b (IV Induction followed by SC maintenance)


Disease Site
Skin - Melanoma

Intent
Adjuvant
Curative

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 treatment of adult patients with high-risk malignant melanoma who are rendered disease-free following resection


Supplementary Public Funding

interferon alfa-2b
New Drug Funding Program (Interferon - Melanoma)

 
B - Drug Regimen

Induction IV:

interferon alfa-2b
20 million units /m² IV (in hospital or cancer clinic) Days 1 to 5 each week for 4 weeks

then

(Continued on next page)

 

Maintenance SC:

interferon alfa-2b
10 million units /m² SC 3 times weekly on alternate days, for 48 weeks (Self-administered)
(Outpatient prescription in 18 MU, 30 MU and 60 MU pens, also available in vials of 10 MU/mL)
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C - Cycle Frequency

Induction IV CYCLE of 28 DAYS
Given in hospital or cancer centre (for initial cycle)

SUBSEQUENT MAINTENANCE CYCLES OF 28 DAYS
For a usual total of 48 weeks

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Other Supportive Care:

Routine prophylaxis of flu-like symptoms with acetaminophen 500-1000 mg before each dose (especially if this adverse effect occurs with early doses).
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

 

Dosage with toxicity

Doses should be held or reduced (50%) for severe toxicity. Consider permanent discontinuation if recurs. 
 

Toxicity

Action

Dose (% of previous dose)

Colitis, pancreatitis

Pulmonary infiltrates/
Pulmonary function impairment

Ischemic disorders

Autoimmune disorders

New or worsening ophthalmological disorders

Severe depression, suicidal behaviour, psychosis, hallucinations, aggressive behaviour

Severe hypersensitivity reaction  

Severe exacerbation of pre-existing neuropsychiatric, autoimmune, ischemic or infective conditions.
 

 

 

 

 

Discontinue

 

 

 

 

 Not applicable

Transient rashes

May continue treatment; treat symptomatically

 

No change

Thyroid dysfunction

Continue if TSH normalized after medication

No change

Dosage with myelosuppression:

  • Reduce dose or hold dose for significant myelosuppression.

 



Hepatic Impairment

Do not use in patients with autoimmune hepatitis.

LFTs (AST and/or ALT)

Action

Dose (% of previous dose)

5 – 10 x ULN

Hold until recovery

50% 

> 10 x ULN

Discontinue

Not applicable 


Renal Impairment

Caution if CrCl < 50 mL/min. Contraindicated in combination therapy with ribavirin in patients with CrCl < 50 ml/min.

 
F - Adverse Effects
Refer to interferon alfa-2b drug monograph(s) for additional details of adverse effects

Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

·         Flu-like symptoms (ie. fever, fatigue, headache, myalgia, rigors/chills)

·         Injection site reactions

·         Anorexia, nausea, diarrhea, vomiting

·         Increases in hepatic function tests (may be severe)

·         Rash (may be severe)

·         Alopecia

·         CNS effects (may be severe)

·         Pneumonitis, Pancreatitis

·         Autoimmune disorders

·         Retinopathy, retinal vein/artery occlusion, detachment

·         Arterial and venous embolism

·         Arrhythmia, cardiac failure

·         Renal failure, rhabdomyolysis

·         Anemia (may be aplastic or hemolytic)

·         Photosensitivity

·         Anaphylaxis

 
G - Interactions
Refer to interferon alfa-2b drug monograph(s) for additional details

May potentiate effects of radiation therapy

 

 

 
H - Drug Administration and Special Precautions
Refer to interferon alfa-2b drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • INDUCTION IV

  • Clinical toxicity assessment of flu-like symptoms, neurotoxicity, psychiatric, ophthalmic, endocrine, cardiovascular, pulmonary, autoimmune, GI adverse effects; regular
  • Baseline ophthalmologic evaluation
  • Baseline and regular CBC
  • Baseline and routine liver and renal function tests and electrolytes
  • Baseline and regular thyroid function tests

    MAINTENANCE SC

  • Clinical toxicity assessment of flu-like symptoms, neurotoxicity, psychiatric, ophthalmic, endocrine, cardiovascular, pulmonary, autoimmune, GI adverse effects; regular
  • CBC at baseline and intermittently as required.
  • Baseline and intermittent liver & renal function tests.
  • Regular thyroid function tests
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • ECG in patients with pre-existing cardiovascular disease or advanced cancer; baseline and regular
  • Blood glucose tests in diabetic patients; baseline and regular
  • Triglyceride levels; baseline and regular
  • Opthalmoscopy; regular

 


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J - Administrative Information
Maintenance phase:  Outpatient prescription for home administration

Approximate Patient Visit
IV induction: 1 to 1.5 hours
Pharmacy Workload (average time per visit)
(IV) 8.432 minutes
Nursing Workload (average time per visit)
(IV) 49.167 minutes
 
K - References

Interferon alfa-2b drug monograph, Cancer Care Ontario Drug Formulary 2014.

Kirkwood JM, Ibrahim IG, Sosmas JA, et al. High-Dose interferon Alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLHIQS-21 vaccine in patients with resected stage 11B-III melanoma: result of intergroup trial E 1694/59512/C509801. J Clin Oncol May 1 ,2001; 19(9): 2370-2380.

Kirkwood JM, Strawderman MH, Ernstoff MS, et al. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group trial EST 1684. J Clin Oncol, 1996; 14: 7-17.


October 2017 Added melanoma disease site; April 2016 - Replaced regimen category with evidence-informed


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L - Other Notes
Interferon Alfa is not listed in the Ontario Drug Benefit Formulary for malignant melanoma. Confirm coverage with other third party prescription plans.
 
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.