Transaminase Level	Bilirubin	Dose
24-HR INFUSION
Less than 2 times ULN	1.5 mg/dl or less	135 mg/m²
2 to less than 10 times ULN	1.5 mg/dl or less	100 mg/m²
Less than 10 times ULN	1.6–7.5 mg/dl or less	50 mg/m²
3-HR INFUSION
Less than 10 times ULN	1.25 mg/dl or less	175 mg/m²
Less than 10 times ULN	1.26–2 times ULN	135 mg/m²
Less than 10 times ULN	2.01–5 times ULN	90 mg/m²
10 times ULN or greater	Greater than 5 times ULN	Avoid use

ULN: upper limit of normal

Abraxane

Breast cancer

IV Infusion: ADULTS, ELDERLY: 260 mg/m² q3wks. For pts who experience severe neutropenia (neutrophils less than 500 cells/mm³ for a wk or longer) or severe sensory neuropathy, reduce dosage to 220 mg/m² for subsequent courses. For recurrence of severe neutropenia or severe sensory neuropathy, reduce dosage to 180 mg/m² q3wks for subsequent courses. For grade 3 sensory neuropathy, hold until resolution to grade 1 or 2, followed by reduced dose for subsequent courses. Dosage of Abraxane for bilirubin greater than 1.5 mg/dl is not known.

NSCLC

IV: ADULTS, ELDERLY: 100 mg/m² on days 1, 8, 15 of each 21-day cycle (in combination with carboplatin).

Adenocarcinoma of pancreas (in combination with gemcitabine)

IV: ADULTS, ELDERLY: 125 mg/m² on days 1, 8, 15 of each 28-day cycle.

Side effects

Expected (90%–70%): Diarrhea, alopecia, nausea, vomiting. Frequent (48%–46%): Myalgia, arthralgia, peripheral neuropathy. Occasional (20%–13%): Mucositis, hypotension during infusion, pain/redness at injection site. Rare (3%): Bradycardia.

Adverse effects/toxic reactions

Neutropenic nadir occurs at median of 11 days. Anemia, leukopenia occur commonly; thrombocytopenia occurs occasionally. Severe hypersensitivity reaction (dyspnea, severe hypotension, angioedema, generalized urticaria) occurs rarely.

Nursing considerations

Baseline assessment

Offer emotional support. Use strict asepsis, protect pt from infection. Check blood counts, particularly neutrophil, platelet count, before each course of therapy or as clinically indicated.

Intervention/evaluation

Monitor CBC, hepatic function tests, vital signs. Monitor for hematologic toxicity (fever, sore throat, signs of local infections, unusual bleeding/bruising), symptoms of anemia (excessive fatigue, weakness). Assess response to medication. Monitor, report diarrhea. Avoid IM injections, rectal temperatures, other traumas that may induce bleeding. Hold pressure to injection sites for full 5 min.

Patient/family teaching

• Hair loss is reversible, but new hair may have different color, texture. • Do not have immunizations without physician’s approval (drug lowers resistance). • Avoid crowds, persons with known infections. • Report signs of infection at once (fever, flu-like symptoms). • Report persistent nausea/vomiting. • Be alert for signs of peripheral neuropathy. • Avoid pregnancy. • Avoid tasks that may require alertness, motor skills until response to drug is established.

palifermin

pal-ee-fer-min

(Kepivance)

classification

PHARMACOTHERAPEUTIC: Keratinocyte growth factor. CLINICAL: Antineoplastic adjunct.

Action

Binds to keratinocyte growth factor receptor, present on epithelial cells of buccal mucosa, tongue, resulting in proliferation, differentiation, migration of epithelial cells. Therapeutic Effect: Reduces incidence, duration of severe oral mucositis.

Pharmacokinetics

Clearance is higher in pts with cancer compared to healthy subjects. Half-life: 4.5 hrs.

Uses

Reduces incidence, duration, severity of severe stomatitis in pts with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support.

Precautions

Contraindications: (Canada) Pts allergic to Escherichia coli–derived proteins. Cautions: None known.

Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is excreted in breast milk. Use only if potential benefit justifies fetal risk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: Binds to heparin, low molecular weight heparins (e.g., enoxaparin), decreasing effectiveness. Administration during or within 24 hrs before or after myelotoxic chemotherapy results in increased severity, duration of oral mucositis. HERBAL: None significant. FOOD: None known. LAB VALUES: May elevate serum lipase, amylase.

Availability (Rx)

Injection, Powder for Reconstitution: 6.25-mg vials.

Administration/handling

IV

Reconstitution • Reconstitute only with 1.2 ml Sterile Water for Injection, using aseptic technique. • Swirl gently to dissolve. Dissolution takes less than 3 min. Do not shake/agitate solution. • Yields final concentration of 5 mg/ml.

Rate of Administration • If heparin is being used to maintain an IV line, use 0.9% NaCl to rinse IV line before and after palifermin administration. • Administer by IV bolus injection.

Storage • Store intact vials in refrigerator. • If reconstituted solution is not used immediately, may be refrigerated for up to 24 hrs. • Before administration, may be warmed to room temperature for up to 1 hr. • Discard if left at room temperature for more than 1 hr, if discolored or particulate forms. • Protect from light.

Indications/routes/dosage

Mucositis (premyelotoxic therapy)

IV: ADULTS, ELDERLY: 60 mcg/kg/day for 3 consecutive days, with 3rd dose 24–48 hrs before chemotherapy.

Mucositis (postmyelotoxic therapy)

IV: ADULTS, ELDERLY: Last 3 doses of 60 mcg/kg/day should be administered after myelotoxic therapy; first of these doses should be administered after, but on the same day of, hematopoietic stem cell infusion and at least 4 days after most recent administration of palifermin.

Side effects

Frequent (62%–28%): Rash, fever, pruritus, erythema, edema. Occasional (17%–10%): Mouth/tongue thickness/discoloration, altered taste, dysesthesia manifested as hyperesthesia, hypoesthesia, paresthesia, arthralgia.

Adverse effects/toxic reactions

Transient hypertension occurs occasionally.

Nursing considerations

Baseline assessment

Assess oral mucous membranes for degree of stomatitis (erythema, white patches, ulceration, bleeding). Offer emotional support.

Intervention/evaluation

Assess for oral inflammation, difficulty swallowing, mucosal bleeding. Offer sponge sticks to wash mouth with water. Monitor pt’s pain level; medicate as necessary for improved pain control.

Patient/family teaching

• Consume bland meals; avoid eating any spicy food. • Rinse mouth often with water; avoid hot, cold liquids. • Take measures to prevent pregnancy.

paliperidone

pal-ee-per-i-done

(Invega, Invega Sustenna)

BLACK BOX ALERT Elderly pts with dementia-related psychosis are at increased risk for mortality due to cerebrovascular events.

classification

PHARMACOTHERAPEUTIC: Benzisoxazole derivative. CLINICAL: Antipsychotic (see p. 67C).

Action

Exact mechanism of action is unknown, but may antagonize dopamine and serotonin receptors. Therapeutic Effect: Suppresses behavioral response in psychosis.

Pharmacokinetics

Absorbed from GI tract. Metabolized in liver. Primarily excreted in urine. Half-life: 23 hrs.

Uses

Oral: Treatment of acute (short-term) and long-term maintenance of schizophrenia. Acute treatment of schizoaffective disorder as monotherapy or as adjunct to mood stabilizers and/or antidepressants. Injection: Acute and maintenance treatment of schizophrenia. OFF-LABEL: Psychosis/agitation related to Alzheimer’s dementia.

Precautions

Contraindications: Sensitivity to risperidone. Cautions: History of cardiac arrhythmias, renal impairment, diabetes mellitus, HF, active seizures or predisposition to seizures, history of seizures, cardiovascular disease, congenital long QT syndrome, concomitant use with other medications that prolong QT interval (e.g., amiodarone, quinidine), pts at risk for aspiration pneumonia. May increase risk of stroke in pts with dementia-related psychosis. CNS depression, medications for hypertension, hypovolemia, high risk for suicide. Pts with breast cancer, other prolactin-dependent tumors, children, adolescents.

Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: Potential for orthostatic hypotension. Age-related renal impairment may require dosage adjustment.

Interactions

DRUG: May decrease effects of dopamine agonists, levodopa. Alcohol, CNS depressants may increase CNS depression. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum creatine phosphatase, uric acid, triglycerides, AST, ALT, prolactin. May decrease serum potassium, sodium, protein, glucose. May cause EKG changes (including prolonged QT interval).

Availability (Rx)

Injection Suspension: 39 mg/0.25 ml, 78 mg/0.5 ml, 117 mg/0.75 ml, 156 mg/ml, 234 mg/1.5 ml.

Tablets, Extended-Release: 1.5 mg, 3 mg, 6 mg, 9 mg, 12 mg.

Administration/handling

PO

• May give without regard to food. • Do not break, crush, dissolve, or divide extended-release tablets.

IM

• Administer 2 initial injections in deltoid muscle (helps attain therapeutic concentration rapidly). • Maintenance doses may be given in gluteal or deltoid muscle.

Indications/routes/dosage

Treatment of schizophrenia

PO: ADULTS, ELDERLY: Initially, 6 mg once daily in the morning. May increase dose in increments of 3 mg/day at intervals of more than 5 days. Range: 3–12 mg/day. ADOLESCENTS (51 KG OR GREATER): Initially, 3 mg once daily. Range: 3–12 mg/day. (50 KG OR LESS): Initially, 3 mg once daily. Range: 3–6 mg/day.

IM: ADULTS, ELDERLY: 234 mg on day 1 followed by 156 mg 1 wk later (second dose may be given 4 days before or after the weekly time point). Maintenance: Initially, 117 mg monthly. Range: 39–234 mg.

Schizoaffective disorder

PO: ADULTS, ELDERLY: 6 mg once daily in the morning. May increase in increments of 3 mg/day at intervals of more than 4 days. Range: 3–12 mg/day.

Dosage in renal impairment

Creatinine Clearance	Oral Dosage	IM Dosage
50–80 ml/min	6 mg/day maximum	156 mg on day 1, then 117 mg 1 wk later Maintenance: 78 mg once monthly
10–49 ml/min	3 mg/day maximum	Not recommended