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REVLIMID® (lenalidomide) capsules for the treatment of multiple myeloma

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treatment with REVLIMID.

Question 1/7

What percentage of patients in the
REVLIMID MCL clinical trial had
stage III-IV disease?
Correct!
The correct answer is:

92% of patients in the REVLIMID MCL
clinical trial had stage III-IV disease.
80%85%92%99%0

Question 2/7

What percentage of patients had
at least 3 prior systemic
anti-lymphoma therapies?
Correct!
The correct answer is:

In the REVLIMID MCL clinical trial, patients had a
median of 4 prior systemic therapies, with 78% of
patients receiving at least 3 prior systemic therapies.
50%60%65%78%0

Question 3/7

What was the median duration of response
(DOR) for patients taking REVLIMID in the
MCL clinical trial?
Correct!
The correct answer is:

The median DOR for patients taking
REVLIMID in the clinical trial was
16.6 months (95% CI: 7.7, 26.7).
A. 10.5 months
C. 16.6 months
B. 12 months
D. 14.8 months

Question 4/7

What was the overall response rate (ORR)
for patients with relapsed or refractory
MCL who were taking REVLIMID?
Correct!
The correct answer is:

The ORR (CR + CRu + PR) in the REVLIMID
MCL clinical trial was 26%
(95% CI: 18.4, 33.9).
A. 10%
C. 20%
B. 15%
D. 26%

Question 5/7

What was the median time to response for
patients in the REVLIMID MCL trial?
Correct!
The correct answer is:

REVLIMID delivered responses for patients
in 2.2 months (median).
3.1 months
5 months
2.2 months
4.5 months

Question 6/7

What is the recommended starting REVLIMID dose for patients with relapsed or refractory MCL with normal renal function?
Correct!
The correct answer is:

The recommended starting dose for patients with relapsed or refractory MCL who are taking REVLIMID and have normal renalfunction is 25 mg. For patients with a creatinine clearance of 30 to <60 mL/min, the starting dose for REVLIMID is 10 mg.
10 mg
20 mg
15 mg
25 mg

Question 7/7

How should blood counts be monitored for patients on REVLIMID treatment?
Correct!
The correct answer is:

CBCs should be monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter.Patients may require dose interruption and/or dose reduction.
Complete blood counts (CBCs) should
be monitored weekly for the first
cycle, every 2 weeks during
cycles 2-4, and monthly thereafter
CBCs should be monitored
only for the first cycle

CI=confidence interval; CR=complete response; CRu=complete response unconfirmed; ORR=overall response rate; PR=partial response; TTR=time to response; DOR was defined as time from the initial response (at least PR) to documented disease progression.


Trial Design Highlights

MCL Trial

  • A multicenter, single-arm, single-agent, open-label study
  • Patients received REVLIMID 25 mgonce daily for 21 days every 28 days

Key Inclusion Criteriab

  • Biopsy-proven MCL with measurable disease by CT scan
  • Disease that is relapsedc after or refractoryd to bortezomib or bortezomib-containing regimene

Efficacy End Points

  • Overall response rate (ORR)f,g
  • Duration of response (DOR)f,h

Other End Points Included

  • Time to response (TTR)f

mcl-hcp-Clinical_Trial_Design_footnotes

Patient Demographics

Baseline Disease Characteristics and Prior Anti-Lymphoma Treatment Total Patients
(N=134)
ECOG Performance Status,a n (%)
  • 0
  • 1
  • 2
  • 3
43 (32)
73 (54)
17 (13)
1 (<1)
Advanced MCL Stage, n (%)
  • III
  • IV
27 (20)
97 (72)
High or Intermediate MIPI Score,b n (%)
90 (67)
High Tumor Burden,c n (%)
77 (57)
Bulky Disease,d n (%)
44 (33)
Extranodal Disease
101 (75)
Number of Prior Systemic
Anti-Lymphoma Therapies, n (%)
  • Median (range)
  • 1
  • 2
4 (2,10)
0 (0)
29 (22)
  • 3
  • ≥4
34 (25)
71 (53)
Number of Subjects Who Received Prior
Regimen Containing, n (%)
  • Anthracycline/mitoxantrone
  • Cyclophosphamide
  • Rituximab
  • Bortezomib
133 (99)
133 (99)
134 (100)
134 (100)
Refractory to Prior Bortezomib
81 (60)
Refractory to Last Prior Therapy
74 (55)
Prior Autologous Bone Marrow or
Stem Cell Transplant, n (%)
39 (29)

a

ECOG=Eastern Cooperative Oncology Group.

b

MIPI=MCL International Prognostic Index.

c

High tumor burden is defined as at least one lesion that is ≥5 cm in diameter or 3 lesions that are ≥3 cm in diameter.

d

Bulky disease is defined as at least one lesion that is ≥7 cm in the longest diameter.

Adverse reactions reported in ≥10% of patients or Grade 3/4 AEs in ≥2 patients, regardless of relationship to REVLIMID

Body System
Adverse Reaction
All AEsa
(N=134)
n (%)
Grade 3/4 AEsb
(N=134)
n (%)
General disorders and administration site conditions
Fatigue 45 (34) 9 (7)
Pyrexiac 31 (23) 3 (2)
Edema peripheral 21 (16) 0
Astheniac 19 (14) 4(3)
General physical health deterioration 3 (2) 2 (1)
Gastrointestinal disorders
Diarrheac 42 (31) 8 (6)
Nauseac 40 (30) 1 (<1)
Constipation 21 (16) 1 (<1)
Vomitingc 16 (12) 1 (<1)
Abdominal painc 13 (10) 5 (4)
Musculoskeletal and connective tissue disorders
Back pain 18 (13) 2 (1)
Muscle spasms 17 (13) 1 (<1)
Arthralgia 11 (8) 2 (1)
Muscular weaknessc 8 (6) 2 (1)
Respiratory, thoracic and mediastinal disorders
Cough 38 (28) 1 (<1)
Dyspneac 24 (18) 8 (6)
Pleural Effusion 10 (7) 2 (1)
Hypoxia 3 (2) 2 (1)
Pulmonary embolism 3 (2) 2 (1)
Respiratory distressc 2 (1) 2 (1)
Oropharyngeal pain 13 (10) 0
Infections and infestations
Pneumoniac,d 19 (14) 12 (9)
Upper respiratory
tract infection
17 (13) 0
Cellulitisc 3 (2) 2 (1)
Bacteremiac 2 (1) 2 (1)
Staphylococcal sepsisc 2 (1) 2 (1)
Urinary tract infectionc 5 (4) 2 (1)
Skin and subcutaneous tissue disorders
Rashg 30 (22) 2 (1)
Pruritus 23 (17) 1 (<1)
Blood and lymphatic system disorders
Neutropenia 65 (49) 58 (43)
Thrombocytopeniac,e 48 (36) 37 (28)
Anemiac 41 (31) 15 (11)
Leukopeniac 20 (15) 9 (7)
Lymphopenia 10 (7) 5 (4)
Febrile neutropeniac 8 (6) 8 (6)
Metabolism and nutrition disorders
Decreased appetite 19 (14) 1 (<1)
Hypokalemia 17 (13) 3 (2)
Dehydrationc 10 (7) 4 (3)
Hypocalcemia 4 (3) 2 (1)
Hyponatremia 3 (2) 3 (2)
Renal and urinary disorders
Renal failiurec 5 (4) 2 (1)
Vascular disorders
Hypotensionc,d 9 (7) 4 (3)
Deep vein thrombosisc 5 (4) 5 (4)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare 13 (10) 0
Squamos cell carcinoma
of skinc
4 (3) 4 (3)
Investigations
Weight decreased 17 (13) 0

a

MCL clinical trial AEs – All treatment emergent AEs with ≥ 10% of subjects.

b

MCL clinical trial Grade 3/4 AEs – All treatment-emergent Grade 3/4 AEs in 2 or more subjects.

c

MCL clinical trial Serious AEs – All treatment-emergent SAEs in 2 or more subjects.

d

AEs where at least one resulted in a fatal outcome.

e

AEs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases).

f

All adverse reactions under Body System of Infections except for rare infections of Public Health interest will be considered listed.

g

All adverse reactions under HLT of Rash will be considered listed.

The following adverse events which have occurred in other indications and not described above have been reported (5-10%) in patients treated with REVLIMID monotherapy for MCL:

  • General disorders and administration site conditions: Chills
  • Musculoskeletal and connective tissue disorders: Pain in extremity
  • Nervous system disorders: Dysguesia, headache, neuropathy peripheral
  • Infections and infestations: Respiratory tract infection, sinusitis, nasopharyngitis
  • Skin and subcutaneous tissue disorders: Dry skin, night sweats

The following serious adverse events not described above and reported in 2 or more patients treated with REVLIMID monotherapy for MCL:

  • Respiratory, Thoracic and Mediastinal Disorders: Chronic obstructive pulmonary disease
  • Infections and Infestations: Clostridium difficile colitis, sepsis
  • Neoplasms benign, malignant and unspecified (incl cysts and polyps): Basal cell carcinoma
  • Cardiac Disorder: Supraventricular tachycardia

Important Dosing Information

  • The capsules should not be opened, broken, or chewed
  • Lenalidomide is primarily excreted unchanged by the kidney. Since elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Monitor renal function
  • Monitor CBCs weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, then monthly thereafter
  • Treatment is continued or modified based on clinical and laboratory findings
  • Dose modification guidelines are recommended to manage Grade 3/4 neutropenia or thrombocytopenia. For other Grade 3/4 toxicities judged to be related to lenalidomide, hold treatment and restart at next lower dose level when toxicity has resolved to ≤Grade 2
  • For Grade 3 or 4 tumor flare reaction (TFR), recommended to withhold treatment with lenalidomide until TFR resolves to ≤Grade 1
  • Patients may require dose interruption and/or reduction
  • Patients may require the use of blood product support and/or growth factors

Indication

REVLIMID® (lenalidomide) is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

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Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program.

Information about the REVLIMID REMS® program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient's underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

  • Females of Reproductive Potential: See Boxed WARNINGS
  • Males: Lenalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm
  • Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to REVLIMID

REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions. REVLIMID capsules contain lactose; risk-benefit of treatment should be evaluated in patients with lactose intolerance

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation of TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤ Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy

ADVERSE REACTIONS

Mantle Cell Lymphoma

  • Grade 3 and 4 adverse events reported in ≥5% of patients treated with REVLIMID in the MCL trial (N=134) included neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%), dyspnea (6%), and febrile neutropenia (6%)
  • Adverse events reported in ≥15% of patients treated with REVLIMID in the MCL trial included neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia (31%), diarrhea (31%), nausea (30%), cough (28%), pyrexia (23%), rash (22%), dyspnea (18%), pruritus (17%), peripheral edema (16%), constipation (16%), and leukopenia (15%)

DRUG INTERACTIONS

Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in MM patients taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

  • PREGNANCY: See Boxed WARNINGS: If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.  There is a REVLIMID pregnancy exposure registry that monitors pregnancy outcomes in females exposed to REVLIMID during pregnancy as well as female partners of male patients who are exposed to REVLIMID. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to REVLIMID to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436
  • LACTATION: There is no information regarding the presence of lenalidomide in human milk, the effects of REVLIMID on the breastfed infant, or the effects of REVLIMID on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from REVLIMID, advise female patients not to breastfeed during treatment with REVLIMID
  • PEDIATRIC USE: Safety and effectiveness have not been established in pediatric patients
  • RENAL IMPAIRMENT: Adjust the starting dose of REVLIMID based on creatinine clearance value and in patients on dialysis

Please see full Prescribing Information, including Boxed WARNINGS.

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Indication

REVLIMID® (lenalidomide) is indicated for the treatment of patients with mantle cell lymphoma

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a