naxitamab

High Alert

Relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in patients who have demonstrated a partial response, minor response, or stable disease to prior therapy (in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF]) .

Contraindicated in:

Severe hypersensitivity;
Uncontrolled hypertension;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Children <1 yr (safety and effectiveness not established).

CV: hypertension, peripheral edema, tachycardia

Derm: ↑sweating, erythema multiforme, urticaria

EENT: blurred vision, impaired vision, mydriasis, photophobia, rhinorrhea, unequal pupils

Endo: hyperglycemia, hypoglycemia

F and E: hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia

GI: ↑liver enzymes, constipation, diarrhea, hypoalbuminemia, nausea, vomiting

GU: urinary retention

Hemat: anemia, lymphocytopenia, neutropenia, thrombocytopenia

Local: injection site reaction

Metab: ↓appetite, weight loss

Neuro: anxiety, fatigue, headache, irritability, neuropathic pain, peripheral neuropathy, sedation, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES), transverse myelitis

Resp: cough

Misc: fever, infusion reactions, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

None reported.

Solution for injection: 4 mg/mL

IV (Adults ): 3 mg/kg/day (max = 150 mg/day) on Days 1, 3, and 5 of each treatment cycle. Repeat treatment cycle every 4 wk until complete response or partial response; then repeat treatment cycle every 4 wk for 5 cycles. Subsequent treatment cycles may be repeated every 8 wk. Discontinue treatment if disease progression or unacceptable toxicity occurs.

Danyelza

Acts as a glycolipid disialoganglioside (GD2)-binding monoclonal antibody that binds to specific cells in the CNS and peripheral nerves, inducing cell lysis through antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity.

Therapeutic effects:

Decreased progression of neuroblastoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Metabolized into small peptides.

Half-Life: 8.2 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	unknown

Explain the purpose and side effects of naxitamab to patient. Do not stop taking drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
Advise patient to notify health care professional immediately if signs and symptoms of infusion-related reactions (swelling of face, eyes, lips, mouth, or tongue; itching; redness on face [flushing]; rash; hives; trouble breathing; cough; wheezing; noisy, high-pitched breathing; feeling faint or dizzy [low BP]) occur.
Advise patient to notify health care professional if signs and symptoms of severe pain (severe pain in abdomen, bones, neck, legs, arms); inflammation of spinal cord (weakness in legs or arms; bladder and bowel problems; pain in back, legs, or abdomen; numbness; tingling; burning sensation); PRES (severe headache; vision changes; changes in mental status [confusion, disorientation, ↓ alertness], difficulty speaking; weakness in arms or legs; seizures); numbness, tingling, or burning sensation in the arms or legs; nervous system problems of the eye (unequal pupil size, blurred vision, trouble focusing your eyes, dilated pupils, ↓ ability to see, sensitivity to light); or problems urinating or emptying your bladder occur.
Instruct patient to immediately report symptoms of hypertension (sudden or severe headache, elevated BP, blurry vision, chest pain).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking Rx, OTC, or herbal products.
Rep: May cause fetal harm. Advise female of reproductive potential to use effective contraception and avoid breastfeeding during therapy and for 2 mo after last dose of naxitamab.

nax-IT-a-mab

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆