mirvetuximab soravtansine (Rx)

Brand and Other Names:Elahere, mirvetuximab soravtansine-gynx
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 100mg/20mL (5mg/mL)

Ovarian Cancer

Indicated for adults with folate receptor–alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1-3 prior systemic treatment regimens

Premedicate with IV corticosteroid and IV/PO antihistamine, antipyretic, and antiemetic

Each cycle is 21 days

6 mg/kg adjusted ideal body weight (AIBW) IV q3Weeks

Continue until disease progression or unacceptable toxicity

Calculate AIBW

  • AIBW = Ideal body weight (IBW [kg]) + 0.4 × (actual weight [kg] – IBW)
  • Female IBW (kg) = 0.9 × height (cm) – 92

Dosage Modifications

Dosage reduction schedule

  • First dose reduction: 5 mg/kg AIBW
  • Second dose reduction: 4 mg/kg AIBW
  • Unable to tolerate 4 mg/kg AIBW: Permanently discontinue

Keratitis/keratopathy

  • Nonconfluent superficial keratitis: Monitor
  • Confluent superficial keratitis, a cornea epithelial defect, or ≥3-line loss in best corrected visual acuity: Withhold dose until improved or resolved, then resume at same dose, or consider dose reduction
  • Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse: Withhold dose until improved or resolved, then reduce by 1 dose level
  • Corneal perforation: Permanently discontinue

Uveitis

  • Grade 1 – rare cell in anterior chamber: Monitor
  • Grade 2 – 1-2+ cell or flare un anterior chamber: Withhold dose until grade ≤1, then resume at same dose
  • Grade 3 – 3+ cell or flare in anterior chamber: Withhold dose until grade ≤1, then reduce by 1 lower dose level
  • Grade 4 – hypopyon: Permanently discontinue

Pneumonitis

  • Grade 1: Monitor
  • Grade 2: Withhold dose until grade ≤1, then resume at same dose or 1 lower dose level
  • Grade 3 or 4: Permanently discontinue

Peripheral neuropathy

  • Grade 2: Withhold dose until grade ≤1, then resume at 1 lower dose level
  • Grade 3 or 4: Permanently discontinue

Infusion-related reactions/hypersensitivity

  • Grade 1: Maintain infusion rate
  • Grade 2
    • Interrupt infusion and administer supportive treatment
    • After recovery from symptoms, resume infusion at 50% of previous rate, and if no further symptoms appear, increase rate as appropriate until infusion completed
    • Administer additional premedication for future cycles
  • Grade 3 or 4
    • Immediately stop infusion and administer supportive treatment
    • Advise patient to seek emergency treatment and immediately notify their healthcare provider if infusion-related symptoms recur
    • Permanently discontinue

Other adverse reactions

  • Grade 3: Withhold dose until grade ≤1, then resume at 1 lower dose level
  • Grade 4: Permanently discontinue

Renal impairment

  • Mild-to-moderate (CrCl 30-90 mL/min): No dose adjustment recommended
  • Severe (CrCl 15 to <30 mL/min) or end-stage renal disease: Unknown

Hepatic impairment

  • Mild (total bilirubin [TB] ULN or TB >1-1.5 x ULN and any AST): No dose adjustment recommended
  • Moderate or severe (TB >1.5 x ULN): Avoid use

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiating

Select patients based on presence of FRα tumor expression using an FDA-approved test

Safety and efficacy not established

No clinically meaningful differences in efficacy or safety were observed between patients aged ≥65 years compared with younger patients

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Interactions

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                Monitor Closely (25)

                • atazanavir

                  atazanavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • chloramphenicol

                  chloramphenicol will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • clarithromycin

                  clarithromycin will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • cobicistat

                  cobicistat will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • conivaptan

                  conivaptan will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • darunavir

                  darunavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                  elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • grapefruit

                  grapefruit will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • idelalisib

                  idelalisib will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • indinavir

                  indinavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • itraconazole

                  itraconazole will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • ketoconazole

                  ketoconazole will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • levoketoconazole

                  levoketoconazole will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • lonafarnib

                  lonafarnib will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • lopinavir

                  lopinavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • mifepristone

                  mifepristone will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • nefazodone

                  nefazodone will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • nirmatrelvir/ritonavir

                  nirmatrelvir/ritonavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • posaconazole

                  posaconazole will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • ritonavir

                  ritonavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • rucaparib

                  rucaparib will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • saquinavir

                  saquinavir will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • stiripentol

                  stiripentol will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • tucatinib

                  tucatinib will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                • voriconazole

                  voriconazole will increase the level or effect of mirvetuximab soravtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 (a CYP3A4 substrate and the cytotoxic component of the antibody drug conjugate for mirvetuximab soravtansine) exposure, which may increase the risk of adverse reactions.

                Minor (0)

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                  Adverse Effects

                  >10%

                  All grades

                  • Vision impairment (50%)
                  • Increased AST (50%)
                  • Fatigue (49%)
                  • Nausea (40%)
                  • Increased ALT (39%)
                  • Keratopathy (37%)
                  • Abdominal pain (36%)
                  • Decreased lymphocytes (35%)
                  • Peripheral neuropathy (33%)
                  • Diarrhea (31%)
                  • Decreased albumin (31%)
                  • Constipation (30%)
                  • Increased alkaline phosphatase (30%)
                  • Dry eye (27%)
                  • Decreased magnesium (27%)
                  • Decreased leukocytes (26%)
                  • Decreased neutrophils (26%)
                  • Decreased hemoglobin (25%)
                  • Vomiting (19%)
                  • Cataract (18%)
                  • Decreased appetite (18%)
                  • Decreased platelets (18%)
                  • Photophobia (17%)
                  • Arthralgia (17%)
                  • Increased creatinine (16%)
                  • Decreased potassium (15%)
                  • Dyspnea (12%)
                  • Abdominal distension (11%)

                  1-10%

                  All grades

                  • Eye pain (10%)
                  • Myalgia (10%)
                  • Infusion related reactions/hypersensitivity (9%)
                  • Pneumonitis (8-9%)
                  • Thrombocytopenia (5%)
                  • Uveitis (1%)

                  Grades 3-4

                  • Keratopathy (9%)
                  • Vision impairment (7%)
                  • Abdominal pain (7%)
                  • Decreased lymphocytes (7%)
                  • Decreased potassium (4%)
                  • Cataract (3%)
                  • Fatigue (3%)
                  • Diarrhea (3%)
                  • Decreased hemoglobin (3%)
                  • Decreased neutrophils (3%)
                  • Dry eye (2%)
                  • Peripheral neuropathy (2%)
                  • Decreased magnesium (2%)
                  • Decreased platelets (2%)
                  • Increased AST/ALT (2%)
                  • Decreased appetite (1%)
                  • Constipation (1%)
                  • Decreased albumin (1%)
                  • Decreased leukocytes (1%)
                  • Increased alkaline phosphatase (1%)
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                  Warnings

                  Black Box Warnings

                  Ocular toxicity

                  • Can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis
                  • Conduct an ophthalmic exam, including visual acuity and slit lamp exam, before initiating every other cycle for the first 8 cycles, and as clinically indicated
                  • Administer prophylactic artificial tears and ophthalmic topical steroids
                  • Withhold for ocular toxicities until improvement and resume at the same or reduced dose
                  • Discontinue for Grade 4 ocular toxicities

                  Contraindications

                  None

                  Cautions

                  Severe, life-threatening, or fatal interstitial lung disease, including pneumonitis may occur; monitor for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams; appropriately investigate to exclude infectious, neoplastic, and other causes for such symptoms

                  Peripheral neuropathy commonly occurs; median time to onset was 1.3 months after initiation; monitor for signs and symptoms of neuropathy (eg, paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, dysesthesia)

                  Based on its mechanism of action, can cause embryo-fetal harm when administered to pregnant females

                  Ocular disorders

                  • Can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis
                  • Ophthalmic examinations required and premedication with lubricating and corticosteroid eye drops before administration
                  • Median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9 months)
                  • Monitor for ocular toxicity and withhold, reduce, or permanently discontinue therapy based on severity and persistence of ocular adverse reactions
                  • Advise patients to avoid use of contact lenses during treatment unless directed by a healthcare provider
                  • Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms

                  Drug interaction overview

                  • DM4 is a CYP3A4 substrate
                  • Strong CYP3A4 inhibitors
                    • Closely monitor
                    • Coadministration with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of adverse reactions
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                  Pregnancy & Lactation

                  Pregnancy

                  Based on its mechanism of action, can cause embryo-fetal harm when administered to pregnant females because it contains a genotoxic compound (DM4) and affects actively dividing cells

                  Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, mirvetuximab soravtansine has the potential to be transmitted from the mother to the developing fetus

                  There are no available human data regarding use in pregnant females to inform a drug-associated risk

                  No reproductive or developmental animal toxicity studies were conducted

                  Advise patients of potential risk to fetus

                  Verify pregnancy status in females of reproductive potential before initiating

                  Contraception

                  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months after last dose

                  Lactation

                  Data are not available regarding presence in human milk or effects on breastfed children or milk production

                  Advise females not to breastfeed during treatment and for 1 month after last dose

                  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.

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                  Pharmacology

                  Mechanism of Action

                  Antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent to kill the targeted cancer cells

                  Upon binding to FRα, mirvetuximab soravtansine is internalized followed by intracellular release of DM4 via proteolytic cleavage

                  DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death

                  Absorption

                  Steady-state reached at ~24 days

                  Peak plasma concentration

                  • Mirvetuximab soravtansine: 137.3 mcg/mL
                  • Unconjugated DM4: 4.11 ng/mL
                  • S-methyl-DM4: 6.98 ng/mL

                  AUC

                  • Mirvetuximab soravtansine: 20.65 h⋅mg/mL
                  • Unconjugated DM4: 530 h⋅ng/mL
                  • S-methyl-DM4: 1848 h⋅ng/mL

                  Distribution

                  Protein bound: >99% (DM4 and S-methyl DM4)

                  Vd: 2.63 L (mirvetuximab soravtansine)

                  Metabolism

                  Monoclonal antibody portion of mirvetuximab soravtansine is expected to be metabolized into small peptides by catabolic pathways

                  Unconjugated DM4 and S-methyl-DM4 undergo metabolism by CYP3A4

                  Elimination

                  Excretion: S-methyl DM4 and DM4-sulfo-SPDB-lysine were detected in urine within 24 hr of infusion as the main metabolites

                  Half-life

                  • Mirvetuximab soravtansine: 4.8 days
                  • Unconjugated DM4: 2.8 days
                  • S-methyl-DM4: 5 days

                  Total plasma clearance

                  • Mirvetuximab soravtansine: 18.9 mL/hr
                  • Unconjugated DM4: 13.8 L/hr
                  • S-methyl-DM4: 4.3 L/hr
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                  Administration

                  IV Incompatibilities

                  NaCl 0.9%

                  IV Compatibilities

                  D5W

                  IV Preparation

                  Follow applicable special handling and disposal procedures

                  Calculate dose (mg) based on patient’s AIBW, total volume (mL) of solution required, and the number of vials needed for any dosage modifications

                  More than 1 vial will be needed for a full dose

                  Remove vials from refrigerator and allow to warm to room temperature

                  Inspect visually for particulate matter and discoloration before administering; solution should appear clear to slightly opalescent to colorless

                  Gently swirl and inspect each vial before withdrawing dose volume for subsequent further dilution

                  Do not shake vial

                  Using aseptic technique, withdraw dose volume for subsequent further dilution

                  Contains no preservatives and is intended for single-dose only; discard any unused drug remaining in vial

                  Dilution

                  • Must dilute with D5W to final concentration of 1-2 mg/mL; incompatible with saline solutions
                  • Do not mix with any other drugs or IV fluids
                  • Determine D5W volume required to achieve final diluted concentration; either remove excess D5W from prefilled IV bag or add calculated volume to a sterile empty IV bag
                  • Then add calculated dose volume to IV bag and gently mix by slowly inverting the bag several times to assure uniform mixing
                  • Do not shake or agitate
                  • If diluted solution if not used immediately, store appropriately (see Storage)

                  Premedication

                  Premedicate with IV corticosteroid and IV/PO antihistamine, antipyretic, and antiemetic

                  Consider additional premedications including corticosteroids the day before administration for patients who experienced infusion-related reactions

                  Example (or equivalent) premedication regimen

                  • Dexamethasone 10 mg IV, diphenhydramine 25-50 mg PO/IV, and acetaminophen 325-650 mg PO/IV at least 30 min before mirvetuximab soravtansine
                  • Antiemetic (5-HT3 serotonin receptor antagonist or appropriate alternative) PO/IV before each dose and thereafter as needed

                  Ophthalmic exams and premedication

                  • Ophthalmic exam
                    • Conduct ophthalmic exam, including visual acuity and slit lamp exam, before initiation every other cycle for the first 8 cycles, and as clinically indicated
                  • Ophthalmic topical steroids
                    • Ophthalmic topical steroid recommended after slit lamp examination
                    • Instill 1 drop in each eye 6 times daily starting the day before each infusion until day 4, THEN
                    • Instill 1 drop in each eye 4 times daily for days 5-8 of each cycle
                  • Lubricating eye drops
                    • Use eye drops at least 4 times daily and as needed during treatment
                    • Instruct patient to use lubricating eye drops and advise to wait at least 10 minutes after ophthalmic topical steroid administration before instilling lubricating eye drops

                  IV Administration

                  Administer premedication

                  Administer as IV infusion only, using a 0.2 or 0.22 μm polyethersulfone (PES) in-line filter; do not substitute other membrane materials

                  Initial dose: Initiate at rate of 1 mg/min; if well tolerated after 30 min, my increase to 3 mg/min; if 3 mg/min well tolerated after 30 min, may increase to 5 mg/min

                  If no infusion-related reactions occur with previous dose, subsequent infusions may be started at maximally tolerated rate and be increased up to maximum of 5 mg/min as tolerated

                  Flush IV line with D5W after infusion completed to ensure delivery of full dose

                  Do not use any other IV fluids for flushing

                  Storage

                  Hazardous drug; follow applicable special handling and disposal procedures

                  Unopened vials

                  • Store vials upright
                  • Refrigerate at 2-8ºC (36-46ºF) until time of preparation
                  • Keep in original carton to protect from light
                  • Do not freeze or shake

                  Diluted solution

                  • If not used immediately, store at 18-25ºC (64.4-77ºF) for no more than 8 hr (including infusion time), OR
                  • Refrigerate at 2-8ºC (36-46ºF) for no more than 12 hr
                  • If refrigerated, allow infusion bag to reach room temperature before administration
                  • After refrigeration, administer diluted infusion solution within 8 hr (including infusion time)
                  • Do not freeze prepared infusion solution
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
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                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  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.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  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
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.