Quadramet (samarium sm 153 lexidronam) dosing, indications, interactions, adverse effects, and more

Sections

Sections samarium sm 153 lexidronam
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

1,850 MBq/mL

Metastatic Bone Pain Relief

1 mCi/kg IV

Through secure in-dwelling catheter over 1 minute, followed with saline flush

Patient should ingest (or given by IV) 500 mL fluid & void as often as possible to minimize bladder radiation exposure

< 16 years old: Safety & efficacy not established

>10%

Thrombocytopenia (69.3%)

Leukopenia (59.3%)

Anemia (40.7%)

Nausea/vomiting (32.7%)

Frequency Not Defined

Arrhythmias

CVA

Ecchymosis

Epistaxis

HTN

Hypotension

Dizziness

Fever

Paresthesia

Pathologic fx

Spinal cord compression

Purpura

Rash

Abdominal pain

Diarrhea

Coagulation d/o

Hematuria

Bronchitis

Chest pain

Pneumonia

Infections

Lymphadenopathy

Oral candidiasis

Pain flare rxn

Myasthenia

Contraindications

Hypersensitivity to drug, similar phosphate compounds, or components of the formulation

Cautions

May cause myelosuppression; recovery may occur after 8 wks; monitor blood counts for at least 8 wks or until adequate marrow recovery; consider current hematologic status and history of myelosuppressive response to other myelotoxic agents prior to therapy; avoid concurrent chemotherapy and external beam radiation therapy unless benefits outweigh risks, due to potential to additive toxicity

Avoid pregnancy

Thrombocytopenia may be a risk factor in patients with disseminated intravascular coagulation

Transient increase in bone pain may occur within 3 days of administration; may manage with analgesics

Use appropriate precautions in handling and disposal of drug product

Incontinent patients may require urinary catherization to reduce radioactive contamination

Does not prevent spinal cord compression

Incontinent patients may require urinary catherization to reduce risk of radioactive contamination of clothes or bed linens

Patients are at risk for hypocalcemia; whether therapy causes electrocardiographic changes or arrhythmias not studied; caution and appropriate monitoring should be given when administering therapy

Patients urine will be radioactive for several hr, take appropriate precautions

Because concomitant hydration recommended to promote urinary excretion of drug, appropriate monitoring and consideration of additional supportive treatment should be used in patients with a history of congestive heart failure or renal insufficiency

Because approximately one third of drug is excreted in urine, clearance may be reduced in patients with renal impairment not known if dose adjustment needed

Pregnancy & Lactation

Pregnancy Category: D

Lactation: discontinue drug or do not nurse

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.

Mechanism of Action

Tetraphosphonate chelating agent that concentrates in bone - precise mechanism unknown

Pharmacokinetics

Metabolism: None

Excretion: urine 20-50%

IV Administration

Over 1 min through in-dwelling catheter

Do not dilute or mix with other solutions

Contains calcium - may form calcium precipitates with chemicals that complex with calcium

Storage

Store frozen at -10°C to -20°C in lead-shielded container

Expires 48 hr after time of calibration (noted on label) or 8 hr after thawing, whichever is earlier

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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

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View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
Compare formulary status to other drugs in the same class.
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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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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