DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
Frontline and Relapse Treatment
Alkylating Agent
melphalan (generic, branded as Alkeran®, Emovela®)
For use in palliative treatment of MM; approved for use throughout disease course (see Remarks)
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV (intravenous injection): 200mg/m2
Oral: 6 mg (3 tablets) daily
Suppression of blood cell counts, hypersensitivity reactions, gastrointestinal toxicity, pulmonary toxicity, infertility, secondary malignancies (leukemia)
Used as high-dose therapy in auto TP; used in combination with prednisone +/- third drug for non-TP patients (MPV, MPR)
Alkylating Agent cyclophosphamide (generic, formerly branded as Cytoxan®)
For the treatment of MM alone or in combination with other agents
IV: 40-50mg/kg divided over 2-5 days
Oral: 300mg/m2 once weekly
Suppression of blood cell counts, infections, urinary tract and renal toxicity, cardiotoxicity, pulmonary toxicity, secondary malignancies, fever, alopecia (IV), nausea, vomiting, diarrhea
Sometimes used to mobilize stem cells from the marrow to the peripheral blood for harvest prior to ASCT; used orally in combination therapies such as CyBorD; used IV in combination therapies such as DCEP and DVPACE.
Alkylating Agent Melphalan flufenamide
Pepaxto® (Oncopeptides)
For the treatment of RRMM in combination with dexamethasone for patients who have received at least four prior lines of therapy whose disease is refractory to at least one PI, one IMiD, and one CD38-directed MAb
Central line IV: 40 mg. over 30 minutes on Day 1 of each 28-day treatment cycle
Fatigue, nausea, diarrhea, fever, respiratory tract infection
Oncopeptides is providing patients continued access to melphalan flufenamide via the Individual Patient Expanded Access Investigational Drug Application (IND) process if deemed appropriate by their treating physician.
Blood counts need to be monitored for leukocytes decrease, platelets decrease, lymphocytes decrease, neutrophils decrease, hemoglobin decrease, and creatinine increase. Can cause embryo-fetal toxicity and secondary malignancies.
PATIENT SUPPORT: Oncopeptides 1-866-522-8894
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
Anthracycline doxorubicin; doxorubicin hydrochloride liposome injection (generic, branded as Doxil®)
In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV regular doxorubicin: 9mg/m2 days 1-4 of a 28-day cycle; 20mg/ m2
IV doxorubicin liposome injection: 30mg/m2 day 1 of a 28day cycle
Cardiotoxicity, secondary cancers, decreased blood cell counts, infusion site reactions, change in the color of urine, infection, lower sperm count, early menopause, hair loss, nausea, vomiting, mouth sores, eye problems, allergic reactions; Doxil also causes hand-foot syndrome
Lipsomal doxorubicin (Doxil) went off patent. Now there is an FDA-approved generic for Doxil as well as generic doxorubicin.
Bispecific T-cell Engager antibody teclistamab (cqyv) Tecvayli® (Janssen)
For the treatment of RRMM in patients who have previously received four or more prior lines of therapy including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody
SQ injection: The recommended dosage of TECVAYLI is step-up doses of 0.06 mg/kg and 0.3 mg/ kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
Pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.
Can cause hepatotoxicity, including fatalities. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated.
Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold in patients with active infection during the step-up dosing schedule.
Monitor complete blood cell counts at baseline and periodically during treatment. Hypersensitivity and local injection site reactions can occur. Withhold or consider permanent discontinuation based on severity.
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
PATIENT SUPPORT: Janssen Biotech, Inc. 1-800-526-7736
Corticosteroid dexamethasone (generic, branded as Decadron®)
No specific FDA approval for myeloma; approved for “palliative management of leukemias and lymphomas.”
Used in almost every regimen for front-line and relapsed MM; not used in maintenance because of side effects from long-term use
Can be given IV; usually given weekly at 40mg orally (10 pills) (“low-dose” dex); as monotherapy, given orally at 40mg 4 days on, 4 days off
Infections, cardiac conditions/ fluid retention, acne, rash, elevated blood glucose, GI disorders, weight gain, coughing, hoarseness, osteoporosis, muscle pain, ophthalmologic disorders, psychiatric effects, sleeplessness
Caution about drug interactions—see Understanding Dex for details. Several studies have demonstrated that reducing dex dose in combination therapy improves tolerance, extending treatment duration and OS. ASH 2015 Karolinska Institute study demonstratred that on achieving at least PR with Rd second-line therapy, continuing with dex in addition to Rev does not add benefit
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
Immunomodulatory drug (IMiD)
GENERIC NAME BRAND NAME INDICATION
thalidomide
Thalomid® (plus dex) (Bristol Myers Squibb)
Approved in combination with dexamethasone for the treatment of newly diagnosed myeloma, but is used throughout the disease course, including for maintenance therapy (without dex)
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
Oral: approved at 200 mg daily, but is rarely given above 100 mg daily because it is effective at lower doses and higher doses are not generally well tolerated
Embryo-fetal toxicity, venous and arterial thromboembolism, peripheral neuropathy, constipation, drowsiness, dizziness, low white blood cell counts, rash
Patients must participate in a REMS (risk assessment and management program); both partners must use contraception. Causes irreversible peripheral neuropathy.
PATIENT SUPPORT: Bristol Myers Squibb 1-800-861-0048 https://www.bmsaccesssupport. bmscustomerconnect.com/
Immunomodulatory drug (IMiD)
lenalidomide
Revlimid® (Bristol Myers Squibb)
Approved throughout the disease course, including as maintenance therapy (without dex)
Oral: 25 mg days 1-21 of a 28day cycle, maintenance 10 mg continuous
Embryofetal toxicity, low white blood cell counts, low platelet counts, venous and arterial thromboembolism, diarrhea, fatigue, anemia, constipation, rash
Patients must participate in a REMS (risk assessment and management program); both partners must use contraception. Given in combination with dex, patients should receive anti-thrombotic prophylaxis (type determined by risk factors). FIRST trial demonstrated the benefit of continuous Rd in newly diagnosed mm patients who are not candidates for transplant.
PATIENT SUPPORT: Bristol Myers Squibb 1-800-861-0048 https://www.bmsaccesssupport. bmscustomerconnect.com/
*As of 3/22 – TEVA Generics offers a generic version of Revlimid. 1-888-838-2872. Prescribing information, boxed warnings, and medication guide can be found here.
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
Immunomodulatory drug (IMiD) pomalidomide
Pomalyst® (Bristol Myers Squibb)
Proteasome inhibitor bortezomib
Velcade® (Takeda)
In combination with dexamethasone for the treatment of patients with mm who have relapsed after at least 2 prior therapies including Revlimid and a proteasome inhibitor
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
Oral: 4 mg days 1-21 of a 28-day cycle Embryofetal toxicity, low white blood cell counts, low red blood cell counts, low platlet counts, venous and arterial thromboembolism, fatigue, weakness, dizziness and confusion, constipation, nausea, diarrhea, neuropathy
Patients must participate in a REMS (risk assessment and management program); both partners must use contraception. Patients should receive anti-thrombotic prophylaxis (type determined by risk factors).
PATIENT SUPPORT: Bristol Myers Squibb 1-800-861-0048 https://www.bmsaccesssupport. bmscustomerconnect.com/
Approved as treatment for myeloma and as retreatment for patients who had previously responded to treatment and who have relapsed at least 6 months after completing prior Velcade treatment.
IV or SQ (subcutaneous injection) at 1.3mg/m2 days 1,4,8,11 every 21 days
Peripheral neuropathy (SQ administration preferred), fatigue, nausea, diarrhea, thrombocytopenia, low blood pressure; more rarely headache, insomnia, fever, back pain, muscle cramps
May be given weekly for patients with PN or other ongoing side effect(s) and for frailer patients; dose may also be reduced to 1.0 mg/m2. Patients should be given antiviral prophylaxis for herpes zoster (shingles) infection.
PATIENT SUPPORT: Takeda Oncology 1-866-835-2233 https://www.velcade.com/support-andresources
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
Proteasome inhibitor carfilzomib Kyprolis® (Amgen)
As a single agent for adult pts w/ RRMM who have received at least 1 or more prior lines of therapy including bortezomib and an IMiD® and have demonstrated disease progression on or within 60 days after last therapy. For the treatment of adult pts with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone; or lenalidomide and dexamethasone; or daratumumab and dexamethasone; or daratumumab and hyaluronidase-fihj and dexamethasone
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV: 10-minute infusion twiceweekly on 2 consecutive days for 3 weeks out of every 4-week cycle-- 20mg/m2 cycle 1, days 1+2; 27mg/m2 cycle 1 days 8,9,15,16 and all future cycles
Fatigue, anemia, thrombocytopenia, shortness of breath, diarrhea, fever, low blood pressure, cardiac failure and other cardiac events, infusion reactions, embryofetal toxicity
Patients with pre-existing heart conditions may be at greater risk for cardiac complications. Outperfomed Vel/dex in rel MM for PFS, OS regardless of age, cytogenetics, prior Rx. Patients should receive antiviral prophylaxis for herpes zoster (shingles) infection.
PATIENT SUPPORT: AMGEN 1-888-427-7478 https://www.amgenassist360.com/patient/
Proteasome inhibitor ixazomib Ninlaro® (Takeda)
In combination with Rev/dex for treatment of patients with MM who have received at least 1 prior therapy
Oral: 4mg on days 1,8,15 of a 28-day cycle Thrombocytopenia, neutropenia, diarrhea, constipation, nausea, vomiting, peripheral neuropathy, peripheral edema (swelling of the feet) rash, liver toxicity, back pain, upper respiratory tract infection
Dose at 3 mg for pts with moderate to severe liver or kidney impairment. Causes embryo-fetal toxicity.
Patients should receive antiviral prophylaxis for herpes zoster (shingles) infection.
PATIENT SUPPORT: Takeda Oncology 1-844-617-6468, option 2 https://www.ninlaro.com/empower
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE GENERIC NAME BRAND NAME INDICATION
Monoclonal antibody (mAb)
daratumumab
Darzalex® and Darzalex Faspro® (Janssen)
IV: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy; in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy; in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a PI; as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an IMid
Injection: In combination with Rd or VMP for newly diagnosed ASCTineligible pts; in combination with VTd in newly dx’d patients eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor; in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy; as monotherapy for pts who have had 3 or more prior lines of therapy if prior therapies included a PI or an IMiD or who are double-refractory to a PI and an IMiD
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV: 16mg/kg weekly for cycles 1-8, every 2 wks cycles 9-24, every 4 wks cycle 25 onward
Injection: 1,800 mg and 30,000 units hyaluronidase given by a healthcare provider under the skin in the stomach area (abdomen) over 3-5 minutes *Different dosing schedules are used for different combinations; please refer to the prescribing information for more detail
IV: Infusion reactions, fatigue, nausea, back pain, fever, cough, low blood cell counts.
Injection: Serious allergic reactions and other severe systemic administrationrelated reactions, injection site reactions, decreases in blood cell counts, changes in blood tests, upper respiratory infection, fatigue, nausea, diarrhea, shortness of breath, trouble sleeping, fever, cough, muscle spasms, back pain, vomiting, cold-like symptoms, peripheral neuropathy, constipation, pneumonia
IV: Patients must be premedicated prior to infusion to reduce/prevent infusion reactions. Patients should receive antiviral prophylaxis for herpes zoster (shingles) infection. Can affect the results of blood tests to match blood type. Interference with SPEP and IFE tests.
Injection: Patients must be premedicated and postmedicated. Patients should receive antiviral prophylaxis for herpes zoster (shingles) infection. Tell your HCP if you have a history of breathing problems, have had shingles, have had or might have a hepatitis B infection, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. Darzalex Faspro™ may harm your unborn baby and it is not known if it passes into your breast milk. Can affect the results of blood tests to match blood type. Interference with SPEP and IFE tests. Is contraindicated in patients with a history of severe hypersensitivity to daratumumab hyaluronidase or any of the components of the formulation.
PATIENT SUPPORT: Janssen 1-877-553-2792 www.JanssenCarePath.com/DARZALEX
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
Monoclonal antibody (mAb)
GENERIC NAME BRAND NAME INDICATION
elotuzumab
Empliciti® (BMS)
In combination with lenalidomide and dex after 1-3 prior therapies. In combination with pomalidomide and dex after at least 2 prior therapies including lenalidomide and a proteasome inhibitor
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV: 10mg/kg once wkly in a 28-day cycle for cycles 1+2; thereafter every other week, days 1 and 15, every 28 days
Infusion reactions, low blood counts, infections, fatigue, diarrhea, fever, constipation, muscle spasms, decreased appetite
Patients should receive anti-thrombotic prophylaxis (type determined by risk factors) for the combination with Rd due to high incidence of deep vein thrombosis and pulmonary embolism. Patients must be premedicated before each dose to prevent infusion reactions.
PATIENT SUPPORT: Bristol-Myers Squibb 1-844-367-5424 https://www.empliciti.com
Monoclonal antibody (mAb)
isatuximab
Sarclisa® (Sanofi Genzyme)
Nuclear export inhibitor selinexor
Xpovio® (Karyopharm)
In combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma
in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
IV: 10mg/kg every week for 4 weeks, then every 2 weeks until disease progression or unacceptable toxicity
Neutropenia, infection, infusion reaction, diarrhea
Patients must be premedicated before each dose to prevent infusion reactions. Can affect the results of blood tests to match blood type. Interference with SPEP and IFE tests. Monitor patients for development of second primary malignancies. Potential for embryo-fetal toxicity.
PATIENT SUPPORT: Sanofi Genzyme 1-833-930-2273
https://www.sanoficareassist.com/sarclisa
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
XVd Oral: 100 mg (five 20mg tablets) taken orally once weekly on Day 1 in combination with bortezomib and dexamethasone
Xd Oral: 80mg (four 20mg tablets) taken in combination with dexamethasone on Days 1 and 3 of each week until disease progression or unacceptable toxicity
Thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, serious infection, neurological toxicity, embryo-fetal toxicity, and cataract
Doctor must carefully monitor blood counts and body weight at baseline and during treatment, especially during the first two months of treatment. Patients should receive a prophylactic anti-nausea agent prior to and during treatment.
PATIENT SUPPORT: Karyopharm 1-877-527-9493 https://www.karyforward.com
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
B-cell maturation antigen (BCMA)-directed antibody belantamab mafodotin
Blenrep® (GlaxoSmithKline)
Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an antiCD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
IV: 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks
Keratopathy, thrombocytopenia, infusion-related reactions, embryo-fetal toxicity
GSK initiated voluntary withdrawal of Blenrep as requested by the FDA based on results from the DREAMM-3 phase III clinical trial which did not meet the requirements of US FDA Accelerated Approval regulations. Patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program will have the option to enroll in a compassionate use program to continue access to treatment. Patients on Blenrep should consult their healthcare provider.
Initiation of the Process of Voluntary Withdrawal of the Biologic License Application for BLENREP®
GlaxoSmithKline - 1-877-768-0092
The most common side effects of BLENREP include vision or eye changes such as findings on eye exam (keratopathy), decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness, and changes in kidney or liver function blood tests. Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment.
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
CAR T-cell therapy Idecabtagene vicleucel
Abecma® (BMS and bluebird bio)
Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
The patient’s own T cells are genetically modified to recognize and attack BCMA on the surface of the patient’s myeloma cells.
Before giving you Abecma, your doctor will prepare your body by giving you chemotherapy for 3 days. Your Abecma dose is administered by an intravenous infusion given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag. For at least 7 days after the infusion you will be monitored daily at the certified healthcare facility where you received your treatment. Premedicate with acetaminophen and an H1-antihistamine. Avoid prophylactic use of dexamethasone or other systemic corticosteroids.
The safety profile of Abecma is well-established and predictable, including cytokine release syndrome (CRS) and neurologic toxicities that are mostly low-grade with early onset and resolution.
The most common side effects of Abecma are fatigue, fever of 100.4°F/38°C or higher, chills or shivering, severe nausea or diarrhea, decreased appetite, headache, dizziness or lightheadedness, confusion, difficulty speaking or slurred speech, cough, difficulty breathing, and fast or irregular heartbeat.
Cytokine Release Syndrome (CRS), neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), hypersensitivity reactions, infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, effects on ability to drive and use machines
Patients must follow a Risk Evaluation and Mitigation Strategy (REMS) called ABECMA REMS
PATIENT SUPPORT: BMS 1-888-805-4555 https://www.celltherapy360.com
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
GENERIC NAME BRAND NAME INDICATION
CAR T-cell therapy ciltacabtagene autoleucel
Carvykti™ (Janssen Oncology and Legend Biotech)
CARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
CARVYKTI is made from a patient’s own white blood cells, collected and reprogrammed to find and attack multiple myeloma cells. It is given to the patient over 30-60 minutes in a one-time, single-dose infusion of chimeric antigen receptor (CAR)-positive viable T cells in one infusion bag. Before you get CARVYKTI, your healthcare provider will give you chemotherapy for 3 days to prepare your body. After getting CARVYKTI, you will be monitored at the certified healthcare facility where you received your treatment for at least 10 days after the infusion.
The most common nonlaboratory adverse reactions are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.
The most common laboratory adverse reactions include thrombocytopenia, neutropenia, anemia, aminotransferase elevation, and hypoalbuminemia.
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Do not administer CARVYKTI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI. Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI. (Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI.
Patients must follow a CARVYKTI REMS program: 1-844-672-0067
PATIENT SUPPORT: Janssen 1-800-559-7875 to reach the MyCARVYKTI Patient Support Program (no website at present)
As of January 12, 2023
DRUGS IN CURRENT USE FOR MULTIPLE MYELOMA
DRUG TYPE
Supportive Care
GENERIC NAME BRAND NAME INDICATION
ROUTE OF ADMINISTRATION, DOSE SIDE EFFECTS REMARKS
bisphosphonate pamidronate
Aredia® (generic)
bisphosphonate
zoledronate, zoledronic acid
Zometa® (Novartis)
For the treatment of osteolytic bone metastases in conjunction with standard antineoplastic therapy
IV: 90mg infused over 2-4 hours once monthly
Renal toxicity, fever, vein irritation, general aches and pains, ONJ (osteonecrosis of the jaw)
Long-term use (5+ years) can lead to atypical fractures of the femur; patients without documented myeloma-related bone disease should not take bisphosphonates
IV: 4 mg over no less than 15 minutes every 3-4 weeks; usually 30-45 minutes once monthly
IV: 4 mg over no less than 15 minutes every 3-4 weeks; usually 30-45 minutes once monthly
Renal toxicity, fever, vein irritation, general aches and pains, ONJ
Long-term use (5+ years) can lead to atypical fractures of the femur; patients without documented myeloma-related bone disease should not take bisphosphonates; dose should be reduced for patients with renal impairment; 500 mg calcium and 400 IU vitamin D should be taken daily.
PATIENT SUPPORT: Novartis 1-800-277-2254 www.patientassistancenow.com
Bone-modifying agent denosumab
Xgeva® (Amgen)
Prevention of skeletal-related events in patients with multiple myeloma
SQ: 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen
Hypocalcemia, ONJ, atypical femoral fracture, embryofetal toxicity, diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache
All patients should receive calcium and vitamin D. Oral exam should be done prior to starting treatment. Patient must be given bridging therapy with a bisphosphonate to prevent rapid bone breakdown if stopping denosumab.
PATIENT SUPPORT
AMGEN 1-866-822-4832 www.xgeva.com/support-tools
Stem cell mobilizer plerixafor
Mozobil® (Genzyme)
For use in combination with GCSF to mobilize hematopoietic stem cells prior to ASCT in patients with NHL or MM
IV: 0.24mg/kg body weight Nausea, vomiting, diarrhea, tiredness, headache, dizziness, joint or muscle pain, injection site reaction, low platelets
May cause embryo-fetal harm
As of January 12, 2023
