ofatumumab SC (Rx)

Brand and Other Names:Kesimpta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution for SC

  • 20mg/0.4mL single-dose prefilled Sensoready pen
  • 20mg/0.4mL single-dose prefilled syringe

Multiple Sclerosis

Indicated for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Initial dose: 20 mg SC at Weeks 0, 1, and 2, followed by

Subsequent doses: 20 mg SC once monthly starting at Week 4

Dosage Modifications

Renal or hepatic impairment

  • Pharmacokinetics have not been studied

Dosing Considerations

Assessments before initiating treatment

  • Hepatitis B virus screening
    • Perform hepatitis B virus (HBV) screening
    • Contraindicated in patients with active HBV confirmed by positive results for hepatitis B surface antigen (HBsAg) and anti-HBV tests
    • Patients who are negative for HBsAg and positive for hepatitis B core antibody (HBcAb+) or are carriers of HBV (HBsAg+): Consult liver disease experts before starting and during treatment
  • Serum immunoglobulins
    • Test for quantitative serum immunoglobulins
    • Patients with low serum immunoglobulins: Consult immunology experts before initiating treatment
  • Vaccinations
    • Administer all live or live-attenuated vaccines according to immunization guidelines at least 4 weeks before initiating, and whenever possible, give inactivated vaccines at least 2 weeks before initiating

Safety and efficacy not established

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Interactions

Interaction Checker

and ofatumumab SC

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory tract infections (39%)

            Systemic injection-related reactions (21%)

            Headache (13%)

            Local injection-site reactions (11%)

            1-10%

            Urinary tract infection (10%)

            Back pain (8%)

            Blood immunoglobulin M decreased (6%)

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            Warnings

            Contraindications

            Active HBV infection

            Cautions

            Local and systemic injection-related reactions observed; management for injection-related reactions depends on the type and severity of the reaction

            Reduction in immunoglobulins may occur; monitor level of immunoglobulins at the beginning, during, and after discontinuation of treatment until B-cell repletion; consider discontinuing therapy if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise

            May cause fetal harm based on animal data.

            Vaccinations

            • May interfere with the effectiveness of inactivated vaccines
            • Safety of immunization with live or live-attenuated vaccines following therapy has not been studied
            • Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation for inactivated vaccines
            • Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion
            • Vaccination of infants born to treated mothers H5
            • In infants of mothers treated during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts
            • Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines
            • Consider an assessment of vaccine immune responses, including consultation with a qualified specialist to determine whether a protective immune response was mounted
            • Inactivated vaccines may be administered, as indicated, prior to recovery from B-cell depletion

            Infections

            • May potentially increase the risk of infections, including serious bacterial, fungal, and new or reactivated viral infections
            • Hepatitis B virus reactivation H5
              • There are no reports of HBV reactivation
              • HBV reactivation and fatal infections caused by HBV, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred at higher IV doses than the recommended dose in MS but for a shorter duration of treatment
              • Monitor and manage following local medical standards to prevent HBV infection or reactivation
            • Progressive multifocal leukoencephalopathy (PML)
              • No cases of PML have been reported
              • PML resulting in death has occurred at substantially higher IV doses than the recommended dose in MS but for a shorter duration of treatment
              • JC virus (JCV) infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies
              • At first sign or symptom suggestive of PML, withhold and perform an appropriate diagnostic evaluation
              • If PML is confirmed, discontinue treatment

            Drug interaction overview

            • Immunosuppressants
              • When initiating ofatumumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ofatumumab, consider potential for increased immunosuppressive effects
              • Not studied in combination with other MS therapies
              • When switching from therapies with immune effects, consider duration and mechanism of action of these therapies because of potential additive immunosuppressive effects when initiating ofatumumab
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate data on developmental risk associated with use in pregnant females

            May cross the placenta and cause fetal B-cell depletion based on animal studies

            Avoid administering live vaccines to neonates and infants exposed to ofatumumab in utero until B-cell recovery occurs

            Contraception

            • Females of childbearing potential: Use effective contraception during treatment and for 6 months after final dose

            Animal data

            • Following administration to pregnant monkeys, increased mortality, depletion of B-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans

            Lactation

            No data available on drug presence in human milk, effects on breastfed infant, or effects on milk production

            Human IgG is excreted in human milk, and potential for drug absorption to lead to B-cell depletion in infant is unknown

            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

            Precise mechanism of action in multiple sclerosis is unknown

            Recombinant human monoclonal immunoglobulin G1 antibody that binds to human CD20, a cell surface antigen expressed on pre-B- and mature B lymphocytes

            Binding to B lymphocytes results in antibody-dependent cellular cytolysis and complement-mediated lysis

            Absorption

            Peak plasma concentration (steady-state): 1.43 mcg/mL

            AUC: 483 mcg⋅hr/mL

            After SC administration, predominantly absorbed via lymphatic system similarly to other therapeutic monoclonal antibodies

            Distribution

            Vd: 5.42 L

            Metabolism

            Expected metabolic pathway is degradation to small peptides and amino acids by ubiquitous proteolytic enzymes

            Elimination

            Clearance: 0.34 L/day

            Half-life: ~16 days

            Eliminated by a target-independent route as with other IgG molecules and a target-mediated route that is related to binding to B-cells

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            Administration

            SC Preparation

            Remove syringe or pen from refrigerator and allow to reach room temperature 15-30 min; do not remove needle cover from prefilled syringe

            To avoid foaming, do not shake

            Visually inspect for particulate matter and discoloration; do not use if liquid contains visible particles or is cloudy

            SC Administration

            SC administration only

            Administer SC in abdomen, thigh, or outer upper arm; do not inject into moles, scars, stretch marks or skin that is tender, bruised, red, scaly, or hard

            Perform first injection under guidance of a healthcare professional

            Sensoready pens and syringes are for single-dose only; discard after use

            See prescribing information for complete administration instructions

            Missed dose

            • Administer as soon as possible without waiting until next scheduled dose
            • Administer subsequent doses at recommended intervals

            Storage

            Prefilled syringe or Sensoready pen

            • Refrigerate at 2-8ºC (36-46ºF); do not freeze
            • Keep in original carton to protect from light
            • To avoid foaming, do not shake
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            Formulary

            FormularyPatient Discounts

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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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.