lenalidomide (Rx)

Brand and Other Names:Revlimid
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 2.5mg
  • 5mg
  • 10mg
  • 15mg
  • 25mg

Myelodysplastic Syndromes

Indicated for 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

10 mg PO qDay; treatment is modified based upon clinical and laboratory findings

Continue treatment until disease progression or unacceptable toxicity

Multiple Myeloma

Treatment

  • Indicated in combination with dexamethasone for treatment of multiple myeloma (MM)
  • 25 mg PO qDay on Days 1-21 of repeated 28-day cycles (use with dexamethasone)
  • Ineligible for auto-HSCT: Continue until disease progression or unacceptable toxicity
  • Dexamethasone schedule
    • 40 mg PO qDay on Days 1-4, 9-12, and 17-20 of each 28-day cycle for first 4 cycles, THEN
    • 40 mg PO qDay on Days 1-4 every 28 days
    • Age >75 yr: 20 mg PO qDay on Days 1, 8, 15, and 22 of each 28-day cycle

Maintenance

  • Indicated as maintenance therapy for MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
  • Initiate after adequate hematologic recovery (ie, ANC ≥1000/mcL and/or platelet counts ≥75,000/mcL)
  • Starting dose: 10 mg PO qDay continuously (ie, Day 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity
  • After 3 cycles: May increase dose to 15 mg PO qDay if tolerated
  • Hematopoietic stem cell mobilization should occur within 4 cycles of a lenalidomide-containing therapy

Mantle Cell Lymphoma

Indicated for MCL in patients whose disease has relapsed or progressed after 2 prior therapies, 1 of which included bortezomib

25 mg PO qDay on Days 1-21 of repeated 28-day cycles; treatment is modified based on clinical or laboratory findings

Continue until disease progression or unacceptable toxicity

Follicular Lymphoma or Marginal Zone Lymphoma

Indicated in combination with a rituximab product, for treatment of patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL)

Rituximab 375mg/m² IV qWeek in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28-day cycle from Cycles 2-5 

Lenalidomide 20 mg PO qDay on Days 1-22 every 28 days up to 12 cycles (Leonard 2019)

Refer to prescribing information for rituximab for dosing

Dosage Modifications (MDS)

Thrombocytopenia within 4 weeks at starting dose 10 mg/day

  • Baseline ≥100,000/mcL
    • Platelets count falls to <50,000/mcL: Interrupt treatment
    • Platelets returns to ≥50,000/mcL: Resume at 5 mg/day
  • Baseline <100,000/mcL
    • Platelets count falls to 50% of baseline: Interrupt treatment
    • If baseline platelets ≥60,000/mcL and returns to ≥50,000/mcL: Resume at 5 mg/day
    • If baseline platelets <60,000/mcL and returns to ≥30,000/mcL: Resume at 5 mg/day

Thrombocytopenia after 4 weeks

  • At starting dose 5 mg/day
    • Platelets count <30,000/mcL or <50,000/mcL with platelet transfusions: Interrupt treatment
    • Platelets return to ≥30,000/mcL (without hemostatic failure): Resume at 2.5 mg/day
  • At starting dose 10 mg/day
    • Platelets count <30,000/mcL or <50,000/mcL with platelet transfusions: Interrupt treatment
    • Platelets count return to ≥30,000/mcL (without hemostatic failure): Resume at 5 mg/day

Neutropenia within 4 weeks at starting dose 10 mg/day

  • Baseline ANC <1,000/mcL
    • ANC falls to <750/mcL: Interrupt treatment
    • ANC return to ≥1,000/mcL: Resume at 5 mg/day
  • Baseline ANC >1,000/mcL
    • ANC falls to <500/mcL: interrupt treatment
    • ANC return to ≥500/mc/L: Resume at 5 mg/day

Neutropenia after 4 weeks

  • At starting dose 5 mg/day
    • ANC <500/mcL for ≥7 days or with fever (≥38.5°C): Interrupt treatment
    • ANC return to ≥500/mcL: Resume at 2.5 mg/day
  • At starting dose 10 mg/day
    • ANC <500/mcL for ≥7 days or with fever (≥38.5°C): Interrupt treatment
    • ANC return to ≥500/mcL: Resume at 5 mg/day

Other grade 3-4 toxicities

  • Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2

Renal impairment

  • CrCl >60 mL/min: No dosage adjustment necessary
  • CrCl 30-60 mL/min: 5 mg PO qDay
  • CrCl <30 mL/min (nondialysis dependent): 2.5 mg PO qDay
  • CrCl <30 mL/min (dialysis dependent): 2.5 mg PO qDay; on dialysis days, administer following dialysis

Dosage Modifications (MM)

Renal impairment

  • MM treatment starting dose
    • Follow same cycle, but decrease dose as listed below
    • CrCl >60 mL/min: Dose adjustment not necessary
    • CrCl 30-60 mL/min: 10 mg PO qDay; consider escalating the dose to 15 mg/day after 2 cycles if the patient tolerates the 10 mg dose without dose-limiting toxicities
    • CrCl <30 mL/min (not requiring dialysis): 15 mg PO every other day
    • CrCl <30 mL/min (requiring dialysis): 5 mg PO qDay; on dialysis days, administer following dialysis
  • MM maintenance dose
    • Follow same cycle, but decrease or increase based on patient tolerance
    • CrCl >60 mL/min: Dose adjustment not necessary
    • CrCl 30-60 mL/min: 5 mg PO qDay
    • CrCl <30 mL/min (not requiring dialysis): 2.5 mg PO every other day
    • CrCl <30 mL/min (requiring dialysis): 2.5 mg PO qDay; on dialysis days, administer following dialysis

Thrombocytopenia

  • During treatment
    • Platelets count fall to <30,000/mcL: Interrupt treatment and following weekly CBC
    • Platelets return to ≥30,000/mcL: Restart at next lower dose, but not <2.5 mg/day
    • For each subsequent drop <30,000/mcL: Interrupt treatment, then when ≥30,000/mcL, resume at next lower dose, but not <2.5 mg/day
  • During maintenance
    • Platelets fall to <30,000/mcL: Interrupt treatment and following weekly CBC
    • Platelets return to ≥30,000/mcL: Resume at next lower dose, continuously for Days 1-28 of repeated 28-day cycle
  • During maintenance at 5 mg/day
    • Platelets fall to <30,000/mcL: Interrupt treatment; do not dose <5 mg/day for Days 1-21 of 28-day cycle
    • Platelets return to ≥30,000/mcL: Resume at 5 mg/day for Days 1-21 of 28-day cycle; do not dose <5 mg/day daily for Days 1-21 of 28-day cycle

Neutropenia

  • During treatment
    • ANC falls to <1,000/mcL: Interrupt treatment, add G-CSF, follow CBC weekly
    • ANC returns to ≥1,000/mcL and neutropenia is the only toxicity: Resume at 25 mg/day or initial starting dose
    • ANC returns to ≥1,000/mcL with other toxicity: Resume at next lower dose, but <2.5 mg/day mg/day
    • For each subsequent drop <1,000/mcL: Interrupt treatment, then when ≥1,000/mcL, resume at next lower dose, but not <2.5 mg/day
  • During maintenance
    • ANC falls to <500/mcL: Interrupt treatment; follow CBC weekly
    • ANC returns to ≥500/mcL: Resume at next lower dose continuously for days 1-28 of repeated 28-day cycle
  • During maintenance at 5 mg/day
    • ANC falls to <500/mcL: Interrupt treatment; do not dose <5 mg/day for Days 1-21 of 28-day cycle
    • ANC returns to ≥500/mcL: Resume at 5 mg/day for Days 1-21 of 28-day cycle; do not dose <5 mg/day daily for Days 1-21 of 28-day cycle

Other grade 3-4 toxicities

  • During treatment or maintenance
    • Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2

Dosage Modifications (MCL)

Thrombocytopenia

  • Platelets falls to <50,000/mcL: Interrupt treatment
  • Platelets return to ≥50,000/mcL: Resume at 5 mg/day less than previous dose; do not dose below 5 mg/day

Neutropenia

  • ANC falls to <1,000/mcL for at least 7 days OR <1,000/mcL with fever (≥38.5°C) OR ANC <500/mcL: Interrupt treatment and follow weekly CBC
  • ANC returns to ≥1,000/mcL: Resume at 5 mg/day less than previous dose; do not dose below 5 mg/day

Other grade 3-4 toxicities

  • Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2

Renal impairment

  • Follow same cycle, but decrease dose as listed below
  • CrCl 30-60 mL/min: 10 mg PO qDay
  • CrCl <30 mL/min: 15 mg PO q48hr
  • ESRD: 5 mg PO qDay; on dialysis days, administer following dialysis

Dosage Modifications (FL or MZL)

Thrombocytopenia

  • Platelets falls <50,000/mcL: Interrupt dose and follow CBC weekly
  • Platelets return to ≥50,000/mcL: If starting dose was 20 mg qDay, resume at 5 mg less than previous dose; do not dose below 5 mg qDay; if starting dose was 10 mg qDay, resume at 5 mg less than previous dose; do not dose below 2.5 mg qDay

Neutropenia

  • ANC falls to <1000/mcL for ≥7 days, OR falls to <1000/mcL with a temperature ≥38.5°C, orOR falls <500/mcL: Interrupt dose and follow CBC weekly
  • ANC returns to ≥1,000/mcL: If starting dose was 20 mg qDay, resume at 5 mg less than previous dose; do not dose below 5 mg qDay; if starting dose was 10 mg qDay, resume at 5 mg less than previous dose; do not dose below 2.5 mg qDay

Other grade 3 or 4 toxicities

  • Other grade 3 or 4 toxicities: Hold dose and restart at physician's discretion at next lower dose level when toxicity has resolved to grade ≤2

Renal impairment

  • CrCl 30-60 mL/min: 10 mg PO qDay; after 2 cycles, may increase to 15 mg qDay if patient has tolerated therapy
  • CrCl <30 mL/min: 5 mg PO qDay
  • ESRD: 5 mg PO qDay; on dialysis days, administer following dialysis

Orphan Designations Indications

Diffuse large-cell B lymphoma

Chronic lymphocytic leukemia: In July 2013, the FDA halted clinical trials because of significant safety concerns; the ORIGIN trial (NCT00910910) showed higher rates of death in patients treated with lenalidomide compared to those treated with chlorambucil

Orphan sponsor

  • Celgene Corporation; 400 Connell Drive, Suite 7000; Berkley Heights, New Jersey 07922

Dosing Considerations

Limitations on use

  • Not indicated for and is not recommended for the treatment of patients with CLL outside of controlled clinical trials

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and lenalidomide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Thrombocytopenia (62%)

            Neutropenia (59%)

            Diarrhea (48%)

            Pruritus (42%)

            Nausea (35%)

            Rash (35%)

            Fatigue (31%)

            Constipation (24%)

            Arthralgia (22%)

            Back pain (21%)

            Peripheral edema (21%)

            Pyrexia (21%)

            Dizziness (20%)

            Headache (20%)

            Cough (19%)

            Muscle cramp (18%)

            Dyspnea (17%)

            URTI (15%)

            Anemia (12%)

            Pneumonia (12%)

            UTI (11%)

            1-10% (critical AEs)

            Tumor flare reaction - MCL (10%)

            Abdominal pain (8%)

            Leukopenia (8%)

            Myalgia (8%)

            Pain (7%)

            Bronchitis (6%)

            Rhinitis (6%)

            Febrile neutropenia (5%)

            Peripheral neuropathy (5%)

            Postmarketing Reports

            Endocrine disorders: Hypothyroidism, hyperthyroidism

            Hepatobiliary disorders: Hepatic failure (including fatality), toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, mixed cytolytic/cholestatic hepatitis, transient abnormal liver laboratory tests

            Immune system disorders: Angioedema, acute graft-versus-host disease (following allogeneic hematopoietic transplant), solid organ transplant rejection

            Infections and infestations: Viral reactivation (eg, hepatitis B, Herpes zoster), progressive multifocal leukoencephalopathy (PML)

            Neoplasms benign, malignant and unspecified (including cysts and polyps): Tumor lysis syndrome, tumor flare reaction

            Respiratory, thoracic and mediastinal disorders: Pneumonitis

            Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)

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            Warnings

            Black Box Warnings

            Embryo-fetal toxicity

            • Thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans
            • Avoid during pregnancy; if taken during pregnancy, likely to cause birth defects or fetal death
            • Prevent pregnancy during treatment by the use of two reliable methods of contraception In females of reproductive potential, obtain 2 negative pregnancy tests before starting treatment
            • Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after treatment
            • Only available through a restricted distribution program, REVLIMID REMS program; information is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436

            Hematologic toxicity (neutropenia and thrombocytopenia)

            • Associated with significant neutropenia and thrombocytopenia
            • 80% of patients with deletion 5q myelodysplastic syndromes (MDS) had to have a dose delay/reduction during the major study; 34% had to have a 2nd 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 myelodysplastic syndromes should monitor CBC weekly for the first 8 weeks of therapy and at least monthly thereafter; reduce dose when necessary
            • Patients may require dose interruption and/or reduction
            • Patients may require use of blood product support and/or growth factors

            Venous and arterial thrombosis

            • Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide with dexamethasone
            • Monitor for signs and symptoms of thromboembolism; advise patients to seek immediate medical care if they develop symptoms (eg, shortness of breath, chest pain, arm or leg swelling)
            • Antithrombotic prophylaxis is recommended

            Contraindications

            Pregnancy; sexually active women of childbearing potential not using 2 forms of contraception

            Demonstrated hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)

            Cautions

            Risk of hematologic toxicity; can cause significant neutropenia and thrombocytopenia (see Dosage Modifications)

            Monitor complete blood counts (CBC) for FL or MZL weekly for first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2- 4, and monthly thereafter; patients may require dose interruption and/or dose reduction

            Increased risk of DVT, PE, MI, and stroke (see Black Box Warnings)

            Renal impairment

            Increased mortality in patients with chronic lymphocytic leukemia observed in a study using single-agent lenalidomide

            Fatal instances of tumor lysis syndrome reported

            Tumor flare reaction (TFR) has occurred during investigational use for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash; tumor flare may mimic progression of disease; may continue treatment if grade 1 or 2 TFR (treat with corticosteroids, NSAIDs, and/or narcotic analgesics), hold treatment for grade 3 or 4 TFR until resolves to ≤Grade 1

            Hepatic failure, including fatalities occurred with lenalidomide in combination with dexamethasone

            Patients treated with lenalidomide (with melphalan and stem cell transplantation) had higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide

            Monitor patients for development of second primary malignancies; take into account both potential benefit of therapy and risk of second primary malignancies when considering therapy

            Impaired stem cell mobilization reported; refer patients who are auto-HSCT candidates to a transplant center early in treatment to optimize the timing of the stem cell collection

            Both hypothyroidism and hyperthyroidism reported: measure thyroid function before initiating and during therapy

            Tumor lysis syndrome reported with therapy; monitor patients at risk closely; take appropriate preventive approaches

            Increased mortality was observed in 2 randomized clinical trials in patients with multiple myeloma when pembrolizumab was added to a thalidomide analogue and dexamethasone; treatment with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

            Angioedema and serious dermatologic reactions

            • Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) reported; DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis; these events can be fatal
            • Patients with prior history of Grade 4 rash associated with thalidomide treatment should not receive lenalidomide
            • Consider interrupting or discontinuing for Grade 2-3 skin rash
            • Discontinue 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

            Drug interactions overview

            • Digoxin
              • Coadministration of lenalidomide (multiple doses of 10 mg/day) with digoxin may increase plasma levels of digoxin; monitor digoxin plasma levels based on clinical judgement and standard practices
            • Therapies that increase risk of thrombosis
              • Use erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, with caution after making a benefit-risk assessment in patients receiving lenalidomide
            • Warfarin
              • Coadministration of lenalidomide with a single-dose of warfarin had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin
              • Expected changes in PT and INR were observed after warfarin administration
              • Unknown whether an interaction between dexamethasone and warfarin
              • Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated during pregnancy (see Contraindications and Black Box Warnings)

            Based on the mechanism of action and findings from animal studies, lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy

            Thalidomide analogue; thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), bone hypoplasticity, absence of bones, external ear abnormalities (including anotia, microtia, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects

            Mortality at or shortly after birth has been reported in ~40% of infants

            Contraception

            • Females
              • Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception (eg, tubal ligation, IUD, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants]), or partner’s vasectomy, and 1 additional effective contraceptive method (eg, male latex or synthetic condom, diaphragm, or cervical cap)
              • Contraception must begin 4 weeks prior to initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of therapy
              • Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy
              • Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed
            • Males
              • Present in the semen of males; therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide and for up to 4 weeks after discontinuing, even if they have undergone a successful vasectomy
              • Male patients taking lenalidomide must not donate sperm

            Pregnancy registry

            • There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide during pregnancy as well as female partners of male patients who are exposed
            • This registry is also used to understand the root cause for the pregnancy
            • Report any suspected fetal exposure to lenalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the manufacturer at 1-888-423-5436

            Lactation

            Unknown if distributed into human breast milk

            Because of the potential for adverse reactions in breastfed infants from lenalidomide, advise women not to breastfeed during treatment

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Thalidomide analog; immunomodulatory and antiangiogenic; inhibits secretion of proinflammatory cytokines; enhances cell-mediated immunity by stimulating proliferation of anti-CD3 stimulated T cells

            Pharmacokinetics

            Half-life: 3 hr

            Peak plasma time: 0.5-6 hr

            Protein bound: 30%

            Excretion: urine (82%)

            Dialyzable: No

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            Administration

            Oral Administration

            Take at about the same time each day

            Swallow capsule whole with water; do not open capsule, chew, or break

            May take with or without food

            Monitor: CBC, Hgb, Hct, pregnancy testing, renal and hepatic function

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.