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lenalidomide

( LEN-a-LID-o-mide )
Funding:
Exceptional Access Program
  • lenalidomide - Anemia due to MDS, with specific criteria
  • lenalidomide - For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation, according to specific criteria.
  • lenalidomide - Treatment of multiple myeloma in combination with dexamethasone in patients who are not candidates
    for autologous stem cell transplant, with specific criteria
  • lenalidomide - In combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma
  • lenalidomide - For the treatment of patients with multiple myeloma with good performance status who have received at least one prior therapy.
Other Name(s): Revlimid®
Appearance: capsule in various strengths
A - Drug Name

lenalidomide

COMMON TRADE NAME(S):   Revlimid®

 
B - Mechanism of Action and Pharmacokinetics

Lenalidomide is an analogue of thalidomide, developed to reduce the dose-limiting side effects of thalidomide such as sedation, constipation, thromboembolism and neuropathy. The mechanism of action of this class of agents remains to be fully characterized, but it is immunomodulatory with anti-inflammatory activity and anti-angiogenic effects. It inhibits TNF-α production, stimulates T and NK cells, reduces serum levels of vascular endothelial growth factor (VEGF), promotes G1 cell cycle arrest and apoptosis of malignant cells.



Absorption
Bioavailability

Oral: Yes. Co-administration with food does not alter the extent of absorption (AUC) but reduces Cmax by 36%.


Distribution

The pharmacokinetics of lenalidomide are linear and dose proportional. There is no accumulation with multiple dosing at the recommended dose. Exposure is 57% higher in multiple myeloma patients than in healthy volunteers.

Cross blood brain barrier?

No information

PPB 23 - 29 %
Metabolism

In vitro, lenalidomide does not appear to be a substrate, inducer or inhibitor of cytochrome P450 enzymes.  It is a weak substrate, but not an inhibitor, of p-glycoprotein. Non-enzymatic hydrolysis of lenalidomide occurs in aqueous media and plasma.

Inactive metabolites Yes
Elimination

Lenalidomide is primarily excreted unchanged by the kidney

Urine 66 % as unchanged drug.
Half-life 3-5 hours
 
C - Indications and Status
Health Canada Approvals:

  • In combination with dexamethasone for the treatment of multiple myeloma in patients who are not eligible for stem cell transplant.

  • For the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Notes:

  • Health Canada limitation of use: NOT indicated in the treatment of patients with chronic lymphocytic leukemia outside of controlled clinical trials (increased risk of death noted compared to single agent chlorambucil).

  • Approval in myelodysplastic syndrome was based on improvements in transfusion dependence, with no benefit in overall survival demonstrated.

  • Not indicated in maintenance treatment post hematopoietic stem cell transplant.

  • Lenalidomide 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. Call 1-888-RevAid-1 or log onto www.RevAid.ca



Other Uses:

  • Palliative treatment of aggressive B-cell lymphomas (e.g. mantle cell lymphoma)
 
D - Adverse Effects

Emetogenic Potential:  

Minimal – No routine prophylaxis; PRN recommended

Extravasation Potential:   Not applicable

The following table contains adverse effects reported mainly in controlled studies with myeloma patients in combination with dexamethasone, where incidence is at least 2% greater than placebo.

ORGAN SITE SIDE EFFECT* (%) ONSET**
Cardiovascular Arrhythmia (<10%) E
Arterial thromboembolism (<10%) E
Cardiotoxicity (<10%) E
Hypertension (9%) E
Venous thromboembolism (9%) E
Dermatological Rash (22%) (may be severe: SJS, TEN, DRESS) E
Skin discolouration (<1%) E
Gastrointestinal Abdominal pain (11%) E
Anorexia (19%) +/- weight loss E
Constipation (42%) E
Diarrhea (39%) E
Dry mouth (8%) E
Dyspepsia (17%) E
Nausea, vomiting (26%) I
General Edema (27%) E
Fatigue (46%) E
Hematological Hemolysis (rare) E
INR / prothrombin time increased (rare) E
Myelosuppression ± infection, bleeding (35%) (grade 3 or 4, includes opportunistic infections, viral reactivation) E
Hepatobiliary Cholecystitis (1%) (may be severe) E
↑ LFTs (rare, may be severe) E  D
Pancreatitis (rare) E
Hypersensitivity Hypersensitivity (<10%) (including angioedema) I
Immune Graft-versus-host disease (GVHD) (post-stem cell transplant; rare) D
Other - Solid organ transplant rejection (rare; may be fatal) E
Metabolic / Endocrine Abnormal electrolyte(s) (15%) (↓ K, ↓ Mg, ↓ Na, ↓ PO4) E
Adrenal insufficiency (rare) D
Hyperglycemia (16%) E
Hyperthyroidism (<10%) D
Hypothyroidism (8%) D
Tumor lysis syndrome (rare) I
Musculoskeletal Musculoskeletal pain (34%) (including muscle cramps) E
Rhabdomyolysis (rare) E  D
Neoplastic Secondary malignancy (7%) D
Nervous System Cognitive disturbance (9%) E
Depression (13%) E
Dizziness (24%) E
Dysgeusia (15%) E
Headache (27%) E
Insomnia (13%) E
Peripheral neuropathy (9%) E
Syncope (3%) (grade 3 or 4) E
Tremor (21%) E
Ophthalmic Blurred vision (17%) E
Conjunctivitis (<10%) E
Renal Renal failure (1%) E
Respiratory Cough, dyspnea (26%) E
Pneumonitis (1%) E


* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days)     E = early (days to weeks)
D = delayed (weeks to months)      L = late (months to years)

The most common side effects for lenalidomide include fatigue, constipation, diarrhea, myelosuppression ± infection/bleeding, musculoskeletal pain, edema, headache, cough/dyspnea, nausea/vomiting and dizziness.

In randomized controlled trials, the incidence of myelosuppression, fatigue, GI, CNS, respiratory, musculoskeletal and skin toxicity, arterial thromboembolism, venous thromboembolism, electrolyte abnormalities, anorexia and infection were higher than in the control arm.

Thromboembolism occurs in 3-5% in MDS patients receiving lenalidomide as a single agent, and is more frequent when lenalidomide is used in combination with dexamethasone (especially high dose for myeloma – up to 18%) with concomitant erythropoietin or other thrombogenic agents (hormone replacement therapy, contraceptives). Arterial thromboembolism has been reported in those with known risk factors and within the first 6 months of use. Patients at risk of arterial thromboembolism should have their hypertension and hyperlipidemia appropriately managed and refrain from tobacco use. Prophylaxis is recommended for at risk patients (e.g. low dose aspirin 81-100 mg/day, low molecular weight heparin or warfarin).

Skin rash is common with lenalidomide therapy and usually resolves within 2-3 weeks; no interruption of treatment is required unless severe (6%). Unselective antihistamine, topical steroids or short course of oral prednisone 10mg/day for 2 weeks may relieve symptoms (Palumbo 2009). Rare, fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) syndrome has also been observed, with rash, eosinophilia, and systemic involvement (e.g. fever, lymphadenopathy, elevated transaminases, renal insufficiency, pneumonitis, myocarditis and/or pericarditis).

Rarely, hypersensitivity pneumonitis-like syndrome has been reported with lenalidomide use. In the case of unexpected respiratory symptoms such as dyspnea on exertion, crackles on physical examination, radiological bilateral ground-glass opacities and non-resolving pneumonia, lenalidomide should be discontinued until further investigation excludes hypersensitivity pneumonitis-like syndrome.

Cases of viral reactivation have been reported and may be fatal, including herpes zoster and hepatitis B virus (HBV) infections. Use with caution in patients with a history of these infections.

Rare, severe cases of hepatotoxicity, including fatalities have been reported in multiple myeloma patients. The mechanism of this toxicity is unknown. Risk factors may include pre-existing or concurrent liver infection, history of hepatic and renal disorders, elevated baseline liver enzymes, and concomitant hepatotoxic medications.

Tumour flare has been reported in investigational studies for CLL and MCL.

Tumour lysis syndrome (TLS) has been observed and may be fatal. Patients at risk such as those with high tumour burden, should receive appropriate prophylaxis and be monitored closely.

An increase in secondary primary malignancies (SPM, including leukemia, lymphoma and solid tumour, as well as basal and squamous skin cancer) has been reported  The risk of SPM should be considered before initiating treatment and standard cancer screening should be used during treatment.

Graft vs. host disease has been reported in post stem cell transplant patients treated with lenalidomide and may be fatal, especially when given within 6 months of allogenic stem cell transplant.

Solid organ transplant (SOT) rejection, including fatal cases, have been reported within 1 to 3 cycles of lenalidomide treatment. Contributing factors may include underlying disease (e.g., amyloidosis), concurrent infections and recent discontinuation or reduction of immunosuppressants. Consider benefit vs risk in patients with a history of SOT before starting lenalidomide.

 
E - Dosing

Lenalidomide 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. Call 1-888-RevAid1 or log onto www.RevAid.ca

Women of child bearing potential must have two negative pregnancy tests before initiating treatment; clinical trials in MDS excluded patients with grade 4 neutropenia.  MDS patients with platelets < 50 x 109/L should not receive lenalidomide.

Consider allopurinol and hydration for patients at risk of tumour lysis as well as thromboembolism prophylaxis for at risk patients (e.g. myeloma with high dose dexamethasone). Optimal control of thyroid function is recommended prior to starting treatment.

Refer to protocol by which patient is being treated.



Adults:

A. Myelodysplastic Syndrome: 
Q 28 days:  10 mg PO daily on days 1 to 21

Dosage with Toxicity:

Dose levels (days 1-21): 10mg daily, 5mg daily, 5mg every other day

Dosage with Hematologic Toxicity

Discontinue treatment if no erythroid response within 4 months of therapy initiation (less than 50% reduction in transfusion requirements or, if not transfused, less than 10 g/L rise in hemoglobin).

 

If myelosuppression develops within 4 weeks of starting treatment at 10 mg daily

Baseline Counts (X109/L)

Counts during therapy (X109/L)

Action

Platelets

 

AND/ OR

ANC*

Platelets

 

AND/ OR

ANC

≥ 100

 

≥ 1

< 50

<0.75

Hold

Restart at 5mg/day when platelets ≥ 50 and ANC ≥ 1

≥60 to <100

 

<1

↓ 50% of baseline

<0.50

Hold

Restart at 5mg/day when platelets ≥ 50 and ANC ≥ 0.5

< 60**

Hold

Restart at 5mg/day when platelets ≥ 30 and ANC ≥ 0.5

 *ANC= Absolute Neutrophil Counts
** Clinical trial excluded patients with platelets < 50 x 109/L or grade 4 ANC.
 
 
 

If myelosuppression develops after 4 weeks of starting treatment at 10 mg daily

Counts during therapy (X109/L)

Action

Platelets

 

AND/ OR

ANC

<30, or <50 requiring transfusion

<0.5 ≥ 7 days or
with fever (≥38.5oC)

Hold

Restart at 5mg/day when platelets ≥ 30 (without bleeding) and ANC ≥ 0.5

If myelosuppression develops during treatment at 5mg daily

Counts during therapy (X109/L)

Action

Platelets

 

AND/ OR

ANC

<30, or <50 requiring transfusion

<0.5 ≥ 7 days or 
with fever (≥38.5oC)

Hold

Restart at 5mg EVERY OTHER DAY when platelets ≥ 30 (without bleeding) and ANC ≥ 0.5

 

Non-Hematologic Toxicities

Toxicity

Action

≥Grade 3 non-hematological

Hold; restart with ↓ 1 dose level when ≤Grade 2.

Grade 2 to 3 rash

Hold or consider discontinuing.  

Discontinue if Stevens-Johnson syndrome suspected.

↑ LFTs

Hold.

Consider restarting at a lower dose when ≤ baseline levels.

Pneumonitis Hold and investigate if suspected; discontinue if confirmed.

Angioedema, OR

Grade 4 skin rash, OR

Exfoliative or bullous rash, OR

Suspected Stevens-Johnson Syndrome, Toxic epidermal necrolysis or DRESS

Discontinue.
Solid organ transplant rejection Discontinue


 

B. Multiple Myeloma:

Q 28 days:    25 mg PO daily on Days 1 to 21 in combination with
                      dexamethasone*: 40 mg PO weekly

*The 40mg weekly dexamethasone option is recommended based on a phase 3 study in newly diagnosed myeloma, where the lower dose was associated with lower mortality and morbidity (Rajkumar 2010). In patients over 75 years of age, the dose should be reduced to 20 mg once weekly.

High-dose dexamethasone may still be appropriate for some patients with acute myeloma complications (e.g. acute renal impairment, hypercalcemia or hyperviscosity syndrome).

 

Dosage with Toxicity

Newly diagnosed (days 1-21):  25mg, 20mg, 15mg, 10mg, 5mg, 2.5mg

Previously treated (days 1-21):  25mg, 20mg, 15mg, 10mg, 5mg

Toxicity (counts x 109/L)

1st Occurrence

Second and Subsequent Occurrence

Hematologic Toxicity (newly diagnosed myeloma)

Platelets < 25

Hold, restart by ↓ 5mg when platelets  ≥ 50.

Hold, restart by ↓ 5mg when platelets ≥ 50.
 

ANC < 0.5 or febrile neutropenia

Hold, start G-CSF. When ANC ≥ 1, restart:

  • Without dose reduction if isolated neutropenia.
  • With 5mg ↓ if other toxicity.

Hold, start G-CSF, restart by ↓ 5mg when ANC ≥ 1.

Hematologic Toxicity (previously treated myeloma)

Platelets < 30

Hold, restart at 15 mg (if 25 mg starting dose)  or 5mg less than the adjusted starting dose, when platelets ≥ 30.

Hold, restart by ↓ 5mg when platelets ≥ 30.

ANC < 1

Hold, start G-CSF, restart when ANC ≥ 1:

  • Without dose reduction if isolated neutropenia.
  • At 15mg (if 25 mg starting dose) or 5mg less than the adjusted starting dose, if other toxicity.

Hold, start G-CSF, restart by ↓ 5mg when ANC ≥ 1.

Non-Hematologic Toxicity

≥ Grade 3 non-hematologic

Hold, restart with ↓ 1 dose level when ≤ Grade 2.

↑ LFTs

Hold.

Consider restarting at a lower dose when ≤ baseline levels.

Grade 2 to 3 rash 

Hold or consider discontinuing.

Discontinue if Stevens-Johnson syndrome suspected.

Angioedema, OR

Grade 4 skin rash, OR

Exfoliative or bullous rash, OR
 
Suspected  Stevens-Johnson syndrome, Toxic epidermal necrolysis or DRESS
Discontinue
Pneumonitis Hold and investigate if suspected; discontinue if confirmed.
Solid organ transplant rejection Discontinue

 



Dosage with Hepatic Impairment:

Population pharmacokinetics suggest no dosage adjustment is necessary in mild hepatic impairment (total bilirubin > 1 to < 1.5 x ULN or AST > ULN). No data available for moderate to severe hepatic impairment.



Dosage with Renal Impairment:

Lenalidomide clearance is decreased while exposure is increased in renal impairment. No dosage adjustment is required for CrCl ≥ 60 ml/min.

Creatinine Clearance (mL/min)

Starting dose in MDS patients

Starting dose in Multiple Myeloma patients

   30 to < 60

5mg daily

10mg daily*

< 30 (not requiring dialysis)

5mg every other day

15mg every other day

< 30 (requiring dialysis)

5mg 3 times a week following each dialysis

No phase III clinical trial experience in this setting.

5 mg once daily. On dialysis days, the dose should be administered following dialysis

* may be escalated to 15 mg q24h after 2 cycles if patient is not responding to treatment and is tolerating the drug.
† maintain a 3 weeks on, 1 week off schedule (q28 days)


Dosage in the elderly:

For transplant ineligible, newly diagnosed myeloma patients over 75 years of age, the concomitant dexamethasone dose should be reduced by half.

The incidences of serious and non-serious adverse events are significantly higher in patients > 65 years (constipation, confusion, dyspnea, atrial fibrillation, diarrhea, fatigue, pulmonary embolism, syncope). May be related to renal impairment. Monitor geriatric patients closely, especially cardiac and renal function. Dose modification based on degree of renal impairment is required.

 



Children:

Safety and efficacy not established.



 
F - Administration Guidelines

  • Oral self-administration; swallow capsules whole; they should not be broken, chewed, or opened. Do not extensively handle the capsules.

  • Give capsules preferably with water, either with or without food. Do not remove from blister packs until ready to take the dose. 
    Note:  Females who could become pregnant, or who plan to become pregnant can handle lenalidomide capsules if they are using latex gloves.

  • If a dose is missed, it may be taken up to 12 hours after the time it is normally taken.  Otherwise, skip this and take the next dose on the following day at its usual scheduled time.

  • Store capsules at room temperature (15 to 30°C)

  • Drug available by outpatient prescription in pharmacy registered with the RevAid® program. Please call 1-888-RevAid-1 or log onto www.RevAid.ca



 
G - Special Precautions
Contraindications:

  • Patients with hypersensitivity (including severe rash) to lenalidomide, pomalidomide, thalidomide or any ingredient in the formulation.

  • MDS patients with platelet counts < 50 x 109/L. MDS patients with grade 3 or 4 thrombocytopenia or grade 4 neutropenia were excluded from clinical trials.

  • Pregnant women.

  • Women at risk of being pregnant and male patients who do not comply with contraception requirements (see Pregnancy section).

  • Breastfeeding women.

  • Not indicated for use in CLL patients outside of clinical trials.

Other Warnings/Precautions:

  • Lenalidomide contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

  • Use with caution and consider venous thromboembolism prophylaxis when used in combination with corticosteroids or thrombogenic agents, such as hormones and erythropoietin (see adverse effects section).

  • Exercise caution in patients with risk factors for arterial thromboembolism (e.g. hypertension and hyperlipidemia), or risk factors for atrial fibrillation (e.g. electrolyte abnormalities, pre-existing heart disease, hypertension, infection).

  • Use with caution in patients with high tumour burden; monitor closely and use appropriate precautions for tumour lysis syndrome.

  • Use with caution and monitor closely in patients with previous viral infections such as HBV and herpes zoster.


Other Drug Properties:

  • Carcinogenicity: Unknown

Pregnancy and Lactation:
  • Teratogenicity: Yes
  • Embryotoxicity: Yes

    Lenalidomide is contraindicated in pregnancy and in females and males 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 lenalidomide). SEE FULL DETAILS ON THE REVAID® PROGRAM. Hormonal contraceptives are not recommended due to the increased risk of thromboembolism.  If pregnancy occurs during treatment, lenalidomide must be discontinued and patient referred to a gynecologist/obstetrician for evaluation and counselling.

    Lenalidomide is present in semen, and there is a potential risk of birth defects, stillbirths and spontaneous abortions in the exposed fetus, 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) and must inform their female sexual partners of the risk.  Male patients should not donate semen while taking lenalidomide and for 4 weeks after cessation.

    Patients should not donate blood while taking lenalidomide and for 4 weeks after stopping therapy to prevent fetal exposure via transfusion of pregnant women.

  • Excretion into breast milk: Unknown

    Breastfeeding is contraindicated.

  • Fertility effects: Unlikely
 
H - Interactions

Lenalidomide is not a substrate, inhibitor or inducer of CYP450; co-administration with substrates or inhibitors of this enzyme is unlikely to result in significant drug interactions.

AGENT EFFECT MECHANISM MANAGEMENT
digoxin ↑ digoxin Cmax - 14% Unknown Caution; monitor digoxin levels
Hormonal therapy (contraception/HRT), erythropoietic agents, corticosteroids ↑ risk of thromboembolic events Additive Caution; monitor carefully; consider prophylaxis with anticoagulants
 
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

Monitor Type Monitor Frequency

RevAid requirements regarding pregnancy tests for women of child-bearing potential

Before starting and as indicated per RevAid

Renal function tests

Baseline and at each visit; increased frequency in patients 65 years or older

Liver function tests

Baseline and at each visit

CBC

 

Baseline and as follows: MDS: weekly for first 8 weeks, then monthly; Myeloma: weekly for the first 8 weeks, on days 1 & 15 of cycle 3, then monthly

Thyroid function tests

Baseline and ongoing

Clinical assessments and grading of cardiac and respiratory symptoms, rash, diarrhea, fatigue, constipation, infection (including viral reactivation), bleeding, tumour lysis syndrome, arterial and venous thromboembolism, GVHD, solid organ transplant rejection (if applicable)

At each visit

Cancer screening for occurrence of second primary malignancy

Assess risk prior to starting treatment; then at each visit or as clinically indicated

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version



Suggested Clinical Monitoring

Monitor Type Monitor Frequency

ECG

Baseline; repeat if arrhythmia suspected

INR in patients receiving warfarin

Baseline and as clinically indicated
 
J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

  • lenalidomide - Anemia due to MDS, with specific criteria
  • lenalidomide - For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation, according to specific criteria.
  • lenalidomide - Treatment of multiple myeloma in combination with dexamethasone in patients who are not candidates for autologous stem cell transplant, with specific criteria
  • lenalidomide - In combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma
  • lenalidomide - For the treatment of patients with multiple myeloma with good performance status who have received at least one prior therapy.

 
K - References

Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma.  NEJM 2007;357:2123-32.

List A, Dewald G, Bennett J, et al. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 2006;355:1456-65.

Palumbo A, Dimopoulos M, San Miguel J. Lenalidomide in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. Blood Reviews 2009;23(2):87-93.

Palumbo A, Rajkumar SV, Dimopoulos MA. Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma. Leukemia 2008;22:414–23.

Product Monograph: Revlimid® (lenalidomide). Celgene Canada, March 2018.

Program in Evidence-Based Care Practice Guideline: Lenalidomide in Multiple Myeloma

Rajkumar SV, Jacobus S, Callander NS, et al; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37.

Shah SR, Tran TM. Lenalidomide in myelodysplastic syndrome and multiple myeloma.  Drugs 2007;67(13):1869-81.

Weber DM, Chen C, Niesvizky R, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. NEJM 2007;357:2133-42.


June 2019 Updated emetic risk category.

 
L - Disclaimer

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.

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