Kyprolis

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Kyprolis Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carfilzomib 10mg, 30mg, 60mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

    Pharmacological Class

    Proteasome inhibitor.

    How Supplied

    Single-use vial—1

    Storage

    Unopened vials should be stored refrigerated 2° C to 8° C (36° F to 46° F).

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Kyprolis Indications

    Indications

    In combination with dexamethasone, or lenalidomide plus dexamethasone, or daratumumab plus dexamethasone, or daratumumab plus hyaluronidase-fihj plus dexamethasone, or isatuximab plus dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received 1–3 lines of therapy. As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥1 lines of therapy.

    Kyprolis Dosage and Administration

    Adult

    See full labeling. Hydrate prior to and following administration as needed. Premedicate with dexamethasone prior to all Cycle 1 doses, during subsequent cycles, and if infusion-related reactions occur. In combination with dexamethasone, daratumumab/dexamethasone, daratumumab/hyaluronidase-fihj/dexamethasone: infuse over 30mins. Once weekly regimen: give once weekly for 3 weeks (Days 1, 8, 15), followed by a 13-day rest period (Days 16–28). In Cycle 1: initially 20mg/m2 per dose on Day 1; if tolerated increase to 70mg/m2 on Day 8 and thereafter.  As monotherapy or in combination with dexamethasone, daratumumab/dexamethasone, daratumumab/hyaluronidase-fihj/dexamethasone, or isatuximab/dexamethasone: infuse over 30mins. Twice weekly regimen: give on two consecutive days each week for 3 weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17–28). In Cycle 1: initially 20mg/m2 per dose on Days 1 and 2; if tolerated increase to 56mg/m2 on Day 8 and thereafter. If given as monotherapy: carfilzomib may be omitted on Days 8 and 9 of Cycle 13 onward. Refer to full labeling for daratumumab, dexamethasone, daratumumab and hyaluronidase-fihj, isatuximab dosing. As monotherapy or in combination with lenalidomide/dexamethasone: infuse over 10mins on two consecutive days each week for 3 weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17–28). In Cycle 1: initially 20mg/m2 per dose on Days 1 and 2; if tolerated increase to 27mg/m2 on Day 8 and thereafter. From Cycle 13, omit the Day 8 and 9 doses. When combined with lenalidomide/dexamethasone, discontinue carfilzomib after Cycle 18. Refer to full labeling for lenalidomide and dexamethasone dosing. All: continue until disease progression or unacceptable toxicity occurs. Mild or moderate hepatic impairment: reduce dose by 25%. ESRD on dialysis: give dose after session. Dose modifications for toxicity: see full labeling.

    Children

    Not established.

    Kyprolis Contraindications

    Not Applicable

    Kyprolis Boxed Warnings

    Not Applicable

    Kyprolis Warnings/Precautions

    Warnings/Precautions

    Monitor for cardiac failure or ischemia; evaluate promptly if toxicity is suspected. Increased risk of cardiac complications in patients with NYHA Class III and IV heart failure, recent MI, conduction abnormalities, angina, uncontrolled arrhythmias; do full medical assessment prior to starting. Withhold therapy if pulmonary hypertension occurs until resolved; consider restarting after reevaluation. Discontinue if pulmonary toxicity occurs. Monitor for tumor lysis syndrome (TLS); interrupt therapy and manage promptly if occurs. Interrupt for Grade 3 or 4 dyspnea until resolved; consider restarting after reevaluation. Maintain adequate hydration. Monitor for volume overload. Evaluate signs/symptoms of blood loss; reduce or withhold dose as appropriate. Monitor for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS); discontinue and evaluate if suspected. Consider progressive multifocal leukoencephalopathy (PML) if new onset or changes in preexisting neurological signs/symptoms. Discontinue and evaluate if posterior reversible encephalopathy syndrome (PRES) or PML is suspected. Optimize BP prior to initiation; withhold and evaluate if uncontrolled. Monitor BP, platelets, renal function, liver enzymes, electrolytes (eg, potassium) regularly; reduce or withhold dose as appropriate. Hepatic impairment. Give thromboprophylaxis for combination therapy. Consider antiviral prophylaxis to prevent herpes zoster reactivation. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥3 months (males w. female partners) after last dose. Pregnancy: avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after last dose).

    Warnings/Precautions

    Cardiac Toxicities 

    • New onset or worsening of pre-existing cardiac failure (eg, congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. Some events occurred in patients with normal baseline ventricular function.
    • Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected.
    • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure.
    • In patients ≥ 75 years of age, the risk of cardiac failure is increased compared to younger patients.
    • Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications; for these patients, complete a comprehensive medical assessment (including blood pressure control and fluid management) prior to starting treatment with Kyprolis and remain under close follow-up.

    Acute Renal Failure

    • Cases of acute renal failure have occurred in patients receiving Kyprolis. Some of these events have been fatal. Renal insufficiency (including renal failure) has occurred in approximately 9% of patients who received Kyprolis.
    • Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy.
    • Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

    Tumor Lysis Syndrome 

    • Cases of TLS, including fatal outcomes, have been reported in patients who received Kyprolis.
    • Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
    • Consider uric acid-lowering drugs in patients at risk for TLS.
    • Monitor for TLS during treatment and manage promptly, including interruption of Kyprolis until TLS is resolved.

    Pulmonary Toxicity 

    • Acute Respiratory Distress Syndrome (ARDS) and acute respiratory failure have occurred in approximately 2% of patients who received Kyprolis. In addition, acute diffuse infiltrative pulmonary disease, such as pneumonitis and interstitial lung disease, occurred in approximately 2% of patients who received Kyprolis. Some events were fatal.
    • In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.

    Pulmonary Hypertension 

    • Pulmonary arterial hypertension was reported in approximately 2% of patients who received Kyprolis, with Grade 3 or greater in less than 1%.
    • Evaluate with cardiac imaging and/or other tests as indicated. 

    Hypertension 

    • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis.
    • Optimize blood pressure prior to starting Kyprolis. Monitor blood pressure regularly in all patients while on Kyprolis. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment. 

    Venous Thrombosis 

    • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with Kyprolis.
    • Provide thromboprophylaxis for patients being treated with Kyprolis in combination with lenalidomide and dexamethasone; with dexamethasone; or with intravenous daratumumab and dexamethasone.
    • Select the thromboprophylaxis regimen based on the patient’s underlying risks.
    • For patients using oral contraceptives or hormonal contraception associated with a risk of thrombosis, consider non-hormonal contraception during treatment when Kyprolis is administered in combination.

    Hemorrhage 

    • Fatal or serious cases of hemorrhage have been reported in patients treated with Kyprolis.
    • Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. The bleeding can be spontaneous and intracranial hemorrhage has occurred without trauma. 
    • Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.

    Thrombocytopenia 

    • Kyprolis causes thrombocytopenia with platelet nadirs observed between Day 8 and Day 15 of each 28-day cycle, with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in approximately 32% of patients in clinical trials with Kyprolis.
    • Hemorrhage may occur.
    • Monitor platelet counts frequently during treatment with Kyprolis. Reduce or withhold dose as appropriate.

    Hepatic Toxicity and Hepatic Failure

    • Cases of hepatic failure, including fatal cases, have been reported (2%) during treatment with Kyprolis.
    • Kyprolis can cause increased serum transaminases.
    • Monitor liver enzymes regularly, regardless of baseline values. Reduce or withhold dose as appropriate.

    Thrombotic Microangiopathy 

    • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/ hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received Kyprolis. Some of these events have been fatal.
    • Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop Kyprolis and evaluate. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted.
    • The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.

    Posterior Reversible Encephalopathy Syndrome 

    • Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis. 
    • Discontinue Kyprolis if PRES is suspected and evaluate.
    • The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.

    Progressive Multifocal Leukoencephalopathy 

    • Progressive multifocal leukoencephalopathy (PML), which can be fatal, has been reported with Kyprolis. In addition to Kyprolis, other possible contributory factors include prior or concurrent immunosuppressive therapy that may cause immunosuppression.
    • Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms.
    • If PML is suspected, discontinue Kyprolis and initiate evaluation for PML including neurology consultation.  

     

    Pregnancy Considerations

    Kyprolis can cause fetal harm based on findings from animal studies and its mechanism of action. There are no available data on Kyprolis use in pregnant women to evaluate for drug-associated risks. Advise pregnant women of the potential risk to the fetus. 

    Conduct pregnancy testing on females of reproductive potential prior to initiating treatment. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose. Advise males with female sexual partners of reproductive potential to use effective contraception during treatment and for 3 months following the last dose. 

    Nursing Mother Considerations

    There is no data on the presence of Kyprolis in human milk, the effects on the breastfed child, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during and for 2 weeks after treatment.

    Pediatric Considerations

    The safety and effectiveness of Kyprolis in pediatric patients have not been established.

    Geriatric Considerations

    No overall differences in effectiveness were observed between older and younger patients.

    Kyprolis Pharmacokinetics

    Distribution

    The mean steady-state volume of distribution of a 20 mg/m2 dose of carfilzomib was 28 L. Carfilzomib is 97% bound to human plasma proteins over the concentration range of 0.4 to 4 micromolar in vitro.

    Metabolism

    Carfilzomib is rapidly metabolized. Peptidase cleavage and epoxide hydrolysis were the principal pathways of metabolism. Cytochrome P450 (CYP)-mediated mechanisms contribute a minor role in overall carfilzomib metabolism.

    Elimination

    Approximately 25% of the administered dose of carfilzomib was excreted in urine as metabolites in 24 hours. Urinary and fecal excretion of the parent compound was negligible (0.3% of total dose). 

    Carfilzomib has a half-life of ≤1 hour on Day 1 of Cycle 1 following intravenous doses ≥15 mg/m2.

    Kyprolis Interactions

    Interactions

    Increased risk of thrombosis with oral or hormonal contraception; consider non-hormonal alternatives during combination therapy. Increased fatal/serious toxicities in combination with melphalan + prednisone in newly diagnosed transplant-ineligible patients.

    Kyprolis Adverse Reactions

    Adverse Reactions

    Anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, hypertension, pyrexia, insomnia, muscle spasm, cough, upper RTI, hypokalemia, nausea, headache, peripheral edema; cardiotoxicity, pulmonary HTN, acute renal failure (may be fatal), infusion-related reactions, hemorrhage, TLS, hepatic toxicity/failure, TTP/HUS, PRES, PML.

    Adverse Reactions

    The most common adverse reactions occurring in ≥20% of patients treated with Kyprolis in monotherapy trials:

    • anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

    The most common adverse reactions occurring in ≥20% of patients treated with Kyprolis in the combination therapy trials: 

    • anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia.

    Kyprolis Clinical Trials

    Clinical Trials

    In combination with lenalidomide and dexamethasone for relapsed or refractory multiple myeloma

    ASPIRE (NCT01080391):

    • A randomized, open-label, multicenter trial that evaluated the combination of carfilzomib with lenalidomide and dexamethasone (KRd) vs lenalidomide and dexamethasone alone (Rd) in 792 patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy.
    • Patients were randomly assigned 1:1 to receive either the KRd (n=396) or Rd arm (n=396). Carfilzomib was administered for a maximum of 18 cycles unless discontinued early for disease progression or unacceptable toxicity. Lenalidomide and dexamethasone administration could continue until progression or unacceptable toxicity. The Rd arm had the same regimen for lenalidomide and dexamethasone as the KRd arm. Concurrent use of thromboprophylaxis and a proton pump inhibitor were required for both arms and antiviral prophylaxis was required for the KRd arm.
    • The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), duration of response (DOR), and overall response rate (ORR).
    • Results showed that patients treated with KRd achieved improved PFS vs those in the Rd arm (hazard ratio [HR], 0.69; 95% CI, 0.57-0.83; 2-sided P =.0001); the median PFS was 26.3 months in the KRd arm vs 17.6 months in the Rd arm.
    • Treatment with KRd achieved improved OS vs Rd (HR, 0.79; 95% CI, 0.67-0.95; 2-sided P =.0091); the median OS was 48.3 months in the KRd arm vs 40.4 months in the Rd arm.
    • The ORR was 87% (95% CI, 83-90) in the KRd arm vs 67% (95% CI, 62-71) in the Rd arm (2-sided P <.0001); the number of responders was 345 in the KRd arm and 264 in the Rd arm.
    • Among the 345 responders in the KRd arm, 56 achieved stringent complete response (sCR), 70 achieved CR, 151 achieved very good partial response (VGPR), and 68 achieved partial response (PR). Among the 264 responders in the Rd arm, 17 achieved sCR, 20 achieved CR, 123 achieved VGPR, and 104 achieved PR.
    • The median DOR was 28.6 months for the responders in the KRd arm vs 21.2 months for the responders in the Rd arm. The median time to response was 1 month (range, 1 to 14 months) in the KRd arm vs 1 month (range, 1 to 16 months) in the Rd arm.

    In combination with dexamethasone for relapsed or refractory multiple myeloma

    ENDEAVOR (NCT01568866):

    • A randomized, open-label, multicenter trial evaluated carfilzomib in combination with dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in 929 patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy.
    • Patients were randomly assigned 1:1 to receive either Kd (n=464) or Vd (n=465) until disease progression or unacceptable toxicity. Concurrent use of thromboprophylaxis was optional, and prophylaxis with an antiviral agent and proton pump inhibitor was required. The primary endpoint was PFS. Secondary endpoints included OS and ORR.
    • Results showed that treatment with Kd achieved improved PFS vs Vd (HR, 0.53; 95% CI, 0.44-0.65; 1-sided P <.0001); the median PFS was 18.7 months in the Kd arm vs 9.4 months in the Vd arm.
    • Treatment with Kd achieved improved OS vs Vd (HR, 0.79; 95% CI, 0.65-0.96; 1-sided P =.01); the median OS was 47.6 months in the Kd arm vs 40.0 months in the Vd arm.
    • The ORR was 77% (95% CI, 73-81) in the Kd arm vs 63% (95% CI, 58-67) in the Vd arm (1-sided P <.0001); the number of responders were 357 in the Kd arm and 291 in the Vd arm.
    • Among the 357 responders in the Kd arm, 8 achieved sCR, 50 achieved CR, 194 achieved VGPR, and 105 achieved PR. Among the 291 responders in the Vd arm, 9 achieved sCR, 20 achieved CR, 104 achieved VGPR, and 158 achieved PR.
    • The median DOR in patients achieving PR or better was 21.3 months in the Kd arm vs 10.4 months in the Vd arm. The median time to response was 1 month (range <1 to 8 months) in both arms.

    In combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma

    CANDOR (NCT03158688):

    • A randomized, open-label, multicenter trial that evaluated carfilzomib 20/56mg/m2 twice weekly in combination with intravenous daratumumab and dexamethasone (DKd) vs carfilzomib 20/56mg/m2 twice weekly and dexamethasone (Kd) in 466 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.
    • Patients were randomly assigned 2:1 to receive either DKd (n=312) or Kd (n=154) until disease progression or unacceptable toxicity. The primary endpoint was PFS. Secondary endpoints included OS and ORR.
    • Results showed that treatment with DKd achieved improved PFS vs Kd (HR, 0.63; 95% CI, 0.46-0.85; 1-sided P =.0014); the median PFS was not estimable in the DKd arm vs 15.8 months in the Kd arm.
    • The ORR was 84% (95% CI, 80-88) in the DKd arm vs 75% (95% CI, 67-81) in the Kd arm (1-sided P =.0040); the number of responders was 263 in the DKd arm and 115 in the Kd arm.
    • Among the 263 responders in the DKd arm, 89 achieved CR, 127 achieved VGPR, and 47 achieved PR. Among the 115 responders in the Kd arm, 16 achieved CR, 59 achieved VGPR, and 40 achieved PR. The median DOR was not reached in the DKd arm vs 16.6 months in the Kd arm. The median time to response was 1 month (range, 1 to 14 months) in the DKd arm and 1 month (range, 1 to 10 months) in the Kd arm.
    • The minimal residual disease negative-complete response occurred in 39 patients in the DKd arm and 2 in the Kd arm (1-sided P <.0001).

    EQUULEUS (NCT01998971):

    • An open-label, multi-cohort trial that evaluated carfilzomib in combination with intravenous daratumumab and dexamethasone in 85 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. Treatment continued until disease progression or unacceptable toxicity. Efficacy results were based on ORR.
    • The ORR was 81% (95% CI, 71-89). Among the 69 responders, 18 achieved sCR, 12 achieved CR, 28 achieved VGPR, and 11 achieved PR.
    • The median time to response was 0.95 months (range, 0.9 to 14.3 months). The median DOR was 28 months (95% CI, 20.5, not estimable).

    PLEIADES (NCT03412565):

    • A multi-cohort, open-label trial that evaluated carfilzomib in combination with daratumumab and hyaluronidase-fihj plus dexamethasone (DKd) in 66 patients with relapsed or refractory multiple myeloma who had received 1 prior line of therapy. Treatment continued until disease progression or unacceptable toxicity. The major efficacy outcome measure was ORR.
    • The ORR was 84.8% (95% CI, 73.9-92.5). Among the 56 responders, 11 achieved sCR, 14 achieved CR, 26 achieved VGPR, and 5 achieved PR.
    • At a median follow-up of 9.2 months, the median DOR had not been reached and an estimated 85.2% (95% CI, 72.5-92.3) maintained response for at least 6 months and 82.5% (95% CI, 68.9-90.6) maintained response for at least 9 months.

    In combination with isatuximab and dexamethasone for relapsed or refractory multiple myeloma

    IKEMA (NCT03275285):

    • A multicenter, multinational, randomized, open-label, 2-arm, phase 3 study that evaluated carfilzomib in combination with isatuximab and dexamethasone (Isa-Kd) in 302 patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.
    • Patients were randomly assigned 3:2 to receive either Isa-Kd (n=179) or carfilzomib and dexamethasone (Kd; n=123) until disease progression or unacceptable toxicity. The median duration of treatment was 80 weeks for the Isa-Kd arm vs 61 weeks for the Kd arm. Efficacy was based upon PFS.
    • Results showed that treatment with Isa-Kd achieved a 45% reduction in the risk of disease progression or death compared with Kd (HR, 0.548; 95% CI, 0.366-0.822; stratified log-rank test P =.0032); the median PFS was not reached in the Isa-Kd arm vs 20.27 months in the Kd arm.
    • The ORR was 86.6% (95% CI, 80.7-91.2) in the Isa-Kd arm and 82.9% (95% CI, 75.1-89.1) in the Kd arm (stratified Cochran-Mantel_Haenszel P =.3859).

    Kyprolis Note

    Not Applicable

    Kyprolis Patient Counseling

    Patient Counseling

    Cardiac Toxicities 

    Advise patients of the risks and symptoms of cardiac failure and ischemia.

    Dehydration 

    Counsel patients to avoid dehydration, since patients receiving Kyprolis therapy may experience vomiting and/or diarrhea. Instruct patients to seek medical advice if they experience symptoms of dehydration.

    Respiratory 

    Advise patients that they may experience cough or shortness of breath (dyspnea) during treatment with Kyprolis. This most commonly occurs within a day of dosing. Advise patients to contact their healthcare provider if they experience shortness of breath.

    Venous Thrombosis

    Inform patients of the risk of venous thromboembolism and discuss the options for prophylaxis. Advise patients to seek immediate medical attention for symptoms of venous thrombosis or embolism.

    Infusion-Related Reactions 

    Advise patients of the risk of infusion-related reactions and discuss the common signs and symptoms of infusion-related reactions with the patients.

    Bleeding

    Inform patients that they may bruise or bleed more easily or that it may take longer to stop bleeding and to report to their healthcare provider any prolonged, unusual or excessive bleeding. Instruct patients on the signs of occult bleeding.

    Hepatic 

    Inform patients of the risk of developing hepatic failure. Advise patients to contact their healthcare provider for symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes.

    Other

    Inform patients to contact their healthcare provider if they experience neurologic symptoms such as headaches, confusion, dizziness or loss of balance, difficulty talking or walking, decreased strength or weakness on one side of the body, seizures, or visual loss.

    Embryo-Fetal Toxicity

    Advise females of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider immediately of a known or suspected pregnancy. Advise female patients to use effective contraceptive during treatment with Kyprolis and for 6 months following the last dose. Advise male patients with female sexual partners of reproductive potential to use effective contraception during treatment with Kyprolis and for 3 months following the last dose.

    Lactation 

    Advise patients to avoid breastfeeding while receiving Kyprolis and for 2 weeks after the last dose.

    Cost Savings Program

    The Kyprolis savings program is available here.

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