See other indications for POMALYST:

Kaposi sarcoma (KS)

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Indication Prescribing Information

This website is intended for U.S. Healthcare Professionals.

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POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

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MM-014 PHASE 2 TRIAL

POMALYST® (pomalidomide) + dex + daratumumab (DPd): Data in first- and second-relapse MM.*

*Results are not included in the Prescribing Information for POMALYST or daratumumab.

Click to see pivotal data for RRMM:

Doublet:

Pd (MM-003)

Triplets:

DPd (EQUULEUS)
Pd + dara SC† (APOLLO)

†Dara SC is daratumumab and hyaluronidase-fihj subcutaneous formulation.

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Trial Design Efficacy Safety

Indication for POMALYST

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab Indication (DPd)

POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj injection for subcutaneous use (dara SC) Indication (Pd + dara SC)

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use:
Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Key study limitations

  • The Phase 2 trial was a single-arm study with no comparator arm
  • The majority of patients received 1 prior line of therapy (70 of 112 patients; 63%)
  • Not all patients must have received a PI, though 80% of patients did receive a PI
  • Differences in outcomes could be due to baseline characteristics or previous lines of therapy
  • PFS was a secondary endpoint of MM-014 and was not statistically tested in the setting of a single-arm trial. PFS data are not in the Prescribing Information and should be interpreted with caution in a single-arm trial. The statistical significance of PFS is not known

DPd, POMALYST + dexamethasone + daratumumab; MM, multiple myeloma; Pd, POMALYST + dexamethasone; Pd + dara SC, POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj subcutaneous; PFS, progression-free survival; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

MM-014 PHASE 2: TRIAL DESIGN

About the MM-014 Phase 2 trial

DPd was studied in a Phase 2, open-label, single-arm, multicenter trial with 3 cohorts that was designed to investigate the outcomes of sequencing a regimen with POMALYST in early relapse and immediately after treatment failure with a REVLIMID® (lenalidomide)* regimen.

  • DPd was studied in 112 adult patients with measurable RRMM who had received 1-2 prior lines of therapy with a REVLIMID-containing regimen in the immediate prior line and an ECOG performance status of ≤2
  • Patients were excluded if they had prior treatment with POMALYST or dara and abnormal laboratory values†
  • ORR was the primary endpoint; secondary endpoints included PFS and safety
POMALYST® (pomalidomide) MM-014 Trial Design POMALYST® (pomalidomide) MM-014 Trial Design

Treatment was administered in 28-day cycles.

*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

†The following laboratory values were exclusionary: absolute neutrophil count <1 x 109/L, platelet count <75 x 109/L (<30 x 109/L for patients in whom ≥50% of bone marrow nucleated cells were plasma cells), corrected serum calcium >2.875 mmol/L (11.5 mg/dL), hemoglobin <80 g/L, AST or ALT >3.0x ULN, serum total bilirubin >34.2 µmol/L (2.0 mg/dL) or 3.0x ULN, and severe renal impairment (CrCl <30 mL/min or requiring dialysis).

‡20 mg for patients ≥75 years of age.

Study sponsored by Bristol Myers Squibb.

Information about DPd does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

POMALYST + dexamethasone + daratumumab Indication

POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

CONTRAINDICATIONS FOR DARATUMUMAB

Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB

  • Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.

MM-014 PHASE 2: PATIENT CHARACTERISTICS

THE MAJORITY OF PATIENTS STUDIED HAD 1 PRIOR LINE OF THERAPY1

Additional patient characteristics1,2

  • 63% of patients received 1 prior line of therapy and 37% of patients received 2 lines of prior therapy
  • All patients had received a prior regimen with REVLIMID
    • Patients who were refractory to REVLIMID: 75% (n=84)
    • Patients who relapsed after REVLIMID: 25% (n=28)
  • Other prior therapies included: ASCT (70%), bortezomib (78%), carfilzomib (10%), and ixazomib (4%)
  • Median patient age was 66.5 years (range: 39-83)
  • The ECOG performance status was 0 in 39%, 1 in 60%, and 2 in 1% of patients
  • R-ISS Stage was I in 30 patients (26.8%), II in 53 patients (47.3%), and III in 8 patients (7.1%)
  • Of 93 patients with available cytogenetic analysis, 21.5% were high risk (presence of del[17p], t[4;14], and/or t[14;16])

ALT, alanine aminotransferase; ASCT, autologous stem cell transplantation; AST, aspartate aminotransferase; CrCl, creatinine clearance; dara, daratumumab; dex, dexamethasone; DPd, POMALYST + dexamethasone + daratumumab; ECOG, Eastern Cooperative Oncology Group; IV, intravenous; ORR, overall response rate; PFS, progression-free survival; PI, proteasome inhibitor; R-ISS, Revised International Staging System; RRMM, relapsed/refractory multiple myeloma; ULN, upper limit of normal.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

MM-014 PHASE 2: EFFICACY

Efficacy results for DPd1,2

MM-014 Trial Overall Response Rate (ORR) Secondary Endpoint for DPd in the MM-014 Trial

Information about DPd does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB (cont’d)

  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab until recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

CI, confidence interval; CR, complete response; DPd, POMALYST + dexamethasone + daratumumab; IMWG, International Myeloma Working Group; ITT, intent-to-treat; ORR, overall response rate; PFS, progression-free survival; PR, partial response; SC, subcutaneous; TEAE, treatment-emergent adverse event; VGPR, very good partial response.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

MM-014 PHASE 2: SAFETY

Safety profile of DPd1,2

Select Grade 3/4 TEAs in the Safety Population

aTEAE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

bReported in ≥3% of the safety population.

The adverse event profile was consistent with the known toxicities of the individual agents.

  • Nearly all patients (97.3%) experienced a TEAE of any grade
  • The most common non-hematologic any-grade TEAE was infections and infestations (85 patients [75.9%]), including 35 (31.3%) with upper respiratory tract infection
  • Any-grade infusion-related reactions were reported in 34 patients (30.4%)
  • 8.6% (7/81) of patients discontinued due to adverse events

Median DoT was 15.9 months for POMALYST, 13.9 months for dex, and 16 months for dara.

Information about DPd does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

MM-014 results are not contained in the POMALYST or daratumumab Prescribing Information.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

Review the expansion of data for POMALYST-containing
regimens, as early as first relapse and in later relapse, after lenalidomide and a PI.

Watch a Video on Combination Regimens with POMALYST® (pomalidomide) (pomalidomide)

Review the expansion of data for POMALYST-containing
regimens, as early as first relapse and in later relapse.

Dr. David Siegel reviews POMALYST data across four trials over 10 years.

This video should be watched in its entirety. Topics are presented for your information only.

Video Chapters

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MM-003 Trial: 5 Median Prior LoT

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EQUULEUS Trial: 4 Median Prior LoT

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APOLLO Trial: 2 Median Prior LoT

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MM-014 Trial: 1 Median Prior LoT

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Conclusion and Important Safety Information

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Choosing a POMALYST Triplet
View Video Transcript

Indications

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab (DPd) is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj (Pd + dara SC) is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use: Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Selected Important Safety Information

POMALYST Boxed WARNINGS: EMBRYO-FETAL TOXICITY, A RESTRICTED DISTRIBUTION PROGRAM – the POMALYST REMS®, and VENOUS AND ARTERIAL THROMBOEMBOLISM.

CONTRAINDICATIONS FOR DARATUMUMAB AND DARA SC

Daratumumab and dara SC are contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab, hyaluronidase, or any of the components of the formulation.

POMALYST Boxed WARNINGS

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
  • Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

Venous and Arterial Thromboembolism

  • Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.

DPd, POMALYST + dexamethasone + daratumumab; DoT, duration of therapy; LoT, lines of therapy; PI, proteasome inhibitor; TEAE, treatment-emergent adverse event.

References: 1. Bahlis NJ, Siegel D, Schiller G, et al. Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. Leuk Lymphoma. 2022 Feb 8;1-11. Online ahead of print. doi: 10.1080/10428194.2022.2030477 2. Siegel DS, Schiller GJ, Samaras C, et al. Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. Leukemia. 2020;34(12):3286-3297. 3. POMALYST [package insert]. Summit, NJ: Celgene Corp.

Learn more about POMALYST once-daily
oral dosing and dose modifications.3

See Dose Modifications

POMALYST Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated for the treatment of adult patients:

  • in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab Indication (DPd)

POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj injection for subcutaneous use (dara SC) Indication (Pd + dara SC)

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use:
Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Important Safety Information for POMALYST, daratumumab, and dara SC

POMALYST Boxed WARNINGS

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
  • Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

Venous and Arterial Thromboembolism

  • Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.

CONTRAINDICATIONS FOR POMALYST

  • Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
  • Hypersensitivity: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients.

CONTRAINDICATIONS FOR DARATUMUMAB

  • Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

CONTRAINDICATIONS FOR DARA SC

  • Daratumumab and hyaluronidase-fihj is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab, hyaluronidase, or any of the components of the formulation.

WARNINGS AND PRECAUTIONS FOR POMALYST

  • Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS for POMALYST
    • Males: Pomalidomide 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 POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
    • Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
  • POMALYST REMS Program: See Boxed WARNINGS
    • Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. 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.
    • Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
  • Venous and Arterial Thromboembolism: See Boxed WARNINGS for POMALYST. 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 choice of regimen should be based on assessment of the patient’s underlying risk factors.
  • Increased Mortality With Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma 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.
  • Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
  • Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
  • Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with POMALYST. 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 reactions can be fatal. Consider POMALYST interruption or discontinuation for Grade 2 or 3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or any other severe cutaneous reactions such as SJS, TEN or DRESS.
  • Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
  • Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
  • Second Primary Malignancies (SPMs):
    • Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
    • Monitor patients for the development of SPMs.
  • Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
  • Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB

  • Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab until recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

WARNINGS AND PRECAUTIONS FOR DARA SC

  • Hypersensitivity and Other Administration Reactions: Daratumumab and hyaluronidase-fihj can cause systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions. Fatal reactions have been reported with daratumumab-containing products, including daratumumab and hyaluronidase-fihj. Permanently discontinue daratumumab and hyaluronidase-fihj for life-threatening reactions.
  • Cardiac Toxicity in Patients With Light Chain (AL) Amyloidosis: Monitor patients with cardiac involvement more frequently for cardiac adverse reactions and administer supportive care as appropriate.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab and hyaluronidase-fihj to allow recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab and hyaluronidase-fihj to allow recovery of platelets.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab administration. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab and hyaluronidase-fihj.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

POMALYST:
The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51%), fatigue and asthenia (47%), upper respiratory tract infection (31%), thrombocytopenia (30%), pyrexia (27%), dyspnea (25%), diarrhea (22%), constipation (22%), back pain (20%), cough (20%), pneumonia (19%), bone pain (18%), edema peripheral (17%), peripheral neuropathy (17%), muscle spasms (15%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48%), thrombocytopenia (22%), and pneumonia (16%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + daratumumab

The most common adverse reactions (≥20%) included neutropenia (95%), lymphopenia (94%), thrombocytopenia (75%), anemia (57%), infusion reactions (50%), fatigue (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), back pain (25%), insomnia (23%), arthralgia (22%), vomiting (21%), dizziness (21%), and chills (20%). Grade 3 or 4 hematology laboratory abnormalities included: neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + dara SC

The most common adverse reactions (≥20%) included fatigue (46%), pneumonia (38%), upper respiratory tract infection (36%), and diarrhea (22%). Grade 3 or 4 hematology laboratory abnormalities included: decreased neutrophils (84%), decreased leukocytes (64%), decreased lymphocytes (59%), decreased platelets (19%), and decreased hemoglobin (16%).

DRUG INTERACTIONS FOR POMALYST

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg.

USE IN SPECIFIC POPULATIONS FOR POMALYST

  • Pregnancy: See Boxed WARNINGS for POMALYST. 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 POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST 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 pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
  • Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
  • Renal Impairment: For patients with severe renal impairment requiring dialysis, reduce POMALYST dosage to 3 mg orally daily. Take dose of POMALYST following hemodialysis on hemodialysis days.
  • Hepatic Impairment: For patients with mild to moderate hepatic impairment, reduce POMALYST dosage to 3 mg orally daily and to 2 mg orally daily in patients with severe hepatic impairment.
  • Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction.

Please see full Prescribing Information for POMALYST, including Boxed WARNINGS.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.