Name of the Alkylating Agents -Nitrogen Mustards Drugs
- Cyclophosphamide
- Ifosfamide
- Chlorambucil
- Melphalan
- Bendamustine
1.Cyclophosphamide
| CYCLOPHOSPHAMIDE |
| Availability: Powder for injection: 500 mg, 1 g, 2 g; Tablets: 25 mg, 50 mg |
| Administration and Handling: May be carcinogenic, mutagenic, teratogenic. Handle with extreme care during preparation/administration. Follow facility procedures for safe handling, administration, and disposal of chemotherapeutic drugs. IV: Reconstitution • Reconstitute each 100 mg with 5 mL Sterile Water for Injection, 0.9% NaCl, or D5W to provide concentration of 20 mg/mL. • Shake to dissolve. • Allow to stand until clear. Rate of administration • Infusion rates vary based on protocol. May give by direct IV injection, IV piggyback, or continuous IV infusion. Storage • Reconstituted solution in 0.9% NaCl is stable for 24 hrs at room temperature or up to 6 days if refrigerated. |
| PO: Give on an empty stomach. If GI upset occurs, give with food. • Do not cut or crush. • To minimize risk of bladder irritation, do not give at bedtime. Don’t cut or crush tablets. |
| Verify that patient isn’t pregnant before administering. Know that dosage may need to be decreased if drug is given with other antineoplastics. Dilute each 100 mg of powder with 5 ml of sterile water for injection, to yield 20 mg/ml. Further dilute with compatible fluid, such as 5% dextrose injection, 5% dextrose and normal saline solution for injection, 5% dextrose and Ringer’s injection, lactated Ringer’s injection, or half-normal saline solution for injection. For I.V. injection, give each 100 mg over at least 1 minute. When giving dosages above 500 mg diluted in 100 to 250 ml of compatible solution, administer over 20 to 60 minutes. Use solution prepared with bacteriostatic water for injection within 24 hours if stored at room temperature or within 6 days if refrigerated. To minimize bladder toxicity, increase patient’s fluid intake during therapy and for 1 to 2 days afterward. Most adults require fluid intake of at least 2 L/day. |
| Usual Dosage (Refer to Individual Protocols): IV: Adults, elderly, children: (Single agent): 40–50 mg/kg in divided doses over 2–5 days or 10–15 mg/kg q7–10 days or 3–5 mg/kg twice wkly. PO: Adults, elderly, children: 1–5 mg/kg/day. |
| Nephrotic Syndrome: PO: Adults, children: 2 mg/kg/day for 60–90 days. Maximum cumulative dose: 168 mg/kg. |
| Hodgkin’s disease; malignant lymphoma; multiple myeloma; leukemia; advanced mycosis fungoides; neuroblastoma; ovarian cancer; breast cancer; and certain other tumors Adults: Initially, 40 to 50 mg/kg I.V. in divided doses over 2 to 5 days, or 10 to 15 mg/kg I.V. q 10 days, or 3 to 5 mg/kg I.V. twice weekly. Children: Initially, 2 to 8 mg/kg or 60 to 250 mg/m2 P.O. or I.V. daily in divided doses for 6 or more days. Maintenance dosage is 2 to 5 mg/kg or 50 to 150 mg/m2 P.O. twice weekly |
| Biopsy-proven nephrotic syndrome in children : Children: 2.5 to 3 mg/kg/day P.O. for 60 to 90 days |
Mechanism of Action:
Inhibits DNA, RNA protein synthesis by cross-linking with DNA, RNA strands. Cell cycle–phase nonspecific. Therapeutic
Effect: Prevents cell growth. Potent immunosuppressant.
Indications:
- Treatment of acute lymphocytic, acute nonlymphocytic, chronic myelocytic, chronic lymphocytic leukemias
- Ovarian, breast carcinomas
- Neuroblastoma
- Retinoblastoma
- Hodgkin’s, non-hodgkin’s lymphomas
- Multiple myeloma
- Mycosis fungoides
- Nephrotic syndrome in children.
Off-label:
Treatment of adrenocortical, bladder, cervical, endometrial, prostatic, testicular carcinomas
- Ewing’s sarcoma, Multiple sclerosis
- Non–small cell, small-cell lung cancer
- Organ transplant rejection, Osteosarcoma
- Ovarian germ cell, primary brain, trophoblastic tumors
- Rheumatoid arthritis, Soft-tissue sarcomas
- Systemic dermatomyositis, Systemic lupus erythematosus
- Wilms’ tumor
Cautions & Contraindications:
- Hypersensitivity to cyclophosphamide.
- Urinary outflow obstruction.
- Severe bone marrow depression
Cautions:
- Severe leukopenia, thrombocytopenia, tumor infiltration of bone marrow, previous therapy with other antineoplastic agents, radiation, renal/hepatic/cardiac impairment, active UTI.
Metabolism and Half- Life:
Well, absorbed from GI tract. Protein binding: 10%–60%. Crosses blood-brain barrier. Metabolized in liver.
Primarily excreted in urine. Removed by hemodialysis.
Half-life: 3–12 hrs.
Drug Interactions:
- CYP2D6 inducers (e.g., carbamazepine, Phenobarbital) may decrease concentration/effect.
- Anthracycline agents (e.g., Doxorubicin, Epirubicin) may increase risk of cardiomyopathy.
- Live virus vaccines may potentiate virus replication, increase vaccine side effects, decrease pt’s antibody response to vaccine.
- May increase serum uric acid.
Side- Effects:
- Expected: Marked leukopenia 8–15 days after initiation.
- Frequent: Nausea, vomiting (beginning about 6 hrs after administration and lasting about 4 hrs); alopecia (33%). Occasional: Diarrhea, darkening of skin/fingernails, stomatitis, headache, diaphoresis.
- Rare: Pain/redness at injection site.
Nursing Considerations
Baseline assessment
- Obtain CBC weekly during therapy or until maintenance dose is established, then at 2- to 3-wk intervals.
- Question history of urinary outlet flow obstruction, hepatic/renal impairment, active infections.
- Obtain urine/serum pregnancy test.
Intervention/evaluation
- Monitor CBC, serum BUN, creatinine, electrolytes, urine output.
- Monitor WBC counts closely during initial therapy.
- Monitor for hematologic toxicity (fever, sore throat, signs of local infection, unusual bruising/bleeding from any site), symptoms of anemia (excessive fatigue, weakness).
- Recovery from marked leukopenia due to myelosuppression can be expected in 17–28 days.
- Assess infusion site for signs of extravasation.
- Monitor hematologic profile to determine degree of hematopoietic suppression. Be aware that leukopenia is an expected drug effect and is used to help determine dosage.
- Monitor urine regularly for RBCs, which may precede hemorrhagic cystitis.
Patient/family teaching
- Encourage copious fluid intake, frequent voiding (assists in preventing cystitis) at least 24 hrs before, during, after therapy.
- Do not have immunizations without physician’s approval (drug lowers resistance). Avoid contact with those who have recently received live virus vaccine.
- Promptly report fever, sore throat, signs of local infection, difficulty or pain with urination, unusual bruising/bleeding from any site.
- Hair loss is reversible, but new hair growth may have different color, texture.
- Avoid pregnancy for up to 1 yr after completion of treatment.
- Tell patient to take tablets on empty stomach. However, if GI upset occurs, instruct him to take them with food.
- Advise patient to promptly report unusual bleeding or bruising, fever, chills, sore throat, cough, shortness of breath, seizures, lack of menstrual flow, unusual lumps or masses, flank or stomach pain, joint pain, mouth or lip sores, or yellowing of skin or eyes.
- Instruct patient to drink 2 to 3 L of fluids daily (unless prescriber has told him to restrict fluids).
- Advise breastfeeding women not to breastfeed while taking this drug.
2. Ifosfamide
| IFOSFAMIDE |
| Availability : Injection, Powder for Reconstitution: (Ifex): 1 g, 3 g. Injection, Solution: 50 mg/mL. |
| Administration/handling: Hemorrhagic cystitis occurs if mesna is not given concurrently. Mesna should always be given with ifosfamide. IV: Reconstitution: Reconstitute vial with Sterile Water for Injection or Bacteriostatic Water for Injection to provide concentration of 50 mg/mL. Shake to dissolve. • Further dilute with 50– 1,000 mL D5W or 0.9% NaCl to provide concentration of 0.6–20 mg/mL. Rate of administration: Infuse over minimum of 30 min. • Give with at least 2,000 mL PO or IV fluid (prevents bladder toxicity). • Give with protectant against hemorrhagic cystitis (i.e., mesna). Storage: Store vials of powder at room temperature. • Refrigerate vials of solution. • After reconstitution with Bacteriostatic Water for Injection, vials and diluted solutions stable for 24 hrs if refrigerated. |
| Follow facility policy for handling antineoplastic agents. Know that drug is usually given with other antineoplastics and hemorrhagic cystitis agent. Mix 20 ml of diluent with 1-g vial or 60 ml of diluent with 3-g vial, to yield a concentration of 50 mg/ml. For smaller concentrations, dilute solution further with normal saline solution, dextrose 5% in water, lactated Ringer’s solution, or sterile water. Administer I.V. slowly over at least 30 minutes. |
| Dosage individualized based on clinical response, tolerance to adverse effects. When used in combination therapy, consult specific protocols for optimum dosage, sequence of drug administration |
| Germ Cell Testicular Carcinoma : IV: Adults: 1,200 mg/m2/day for 5 consecutive days. Repeat q3wks or after recovery from hematologic toxicity. Administer with mesna and hydration (to prevent bladder toxicity). |
Mechanism of Action:
Inhibits DNA, protein synthesis by crosslinking with DNA strands, preventing cell growth.
Therapeutic Effect: Produces cellular death (apoptosis).
Indications:
- Treatment of germ cell testicular carcinoma (used in combination with other chemotherapy agents and with concurrent mesna for prophylaxis of hemorrhagic cystitis).
OFF-LABEL:
- Small-cell lung, non–small-cell lung, ovarian, cervical, bladder cancer
- Soft tissue sarcomas
- Hodgkin’s, non-hodgkin’s lymphomas
- Osteosarcoma
- Head and neck, ewing’s sarcoma.
Cautions & Contraindications:
- Hypersensitivity to ifosfamide.
- Urinary outflow obstruction.
- Severe bone marrow depression
- Pregnancy or breastfeeding
Cautions:
Renal/hepatic impairment compromised bone marrow reserve, active urinary tract infection, preexisting cardiac disease, prior radiation therapy. Avoid use in pts with WBCs less than 2,000 cells/mm3 and platelets less than 50,000 cells/mm3.
Metabolism and Half- life:
Metabolized in liver. Protein binding: negligible. Crosses blood-brain barrier (to a limited extent).
Primarily excreted in urine. Removed by hemodialysis.
Half-life: 11–15 hrs (high dose); 4–7 hrs (low dose).
Drug Interactions:
- Bone marrow depressants (e.g., cladribine) may increase myelosuppression.
- Live virus vaccines may potentiate virus replication, increase vaccine side effects, decrease pt’s antibody response to vaccine.
- May increase serum BUN, bilirubin, creatinine, uric acid, ALT, AST.
Side- Effects:
- Frequent (83%–58%): Alopecia, nausea, vomiting.
- Occasional (15%–5%): Confusion, drowsiness, hallucinations, infection.
- Rare (less than 5%): Dizziness, seizures, disorientation, fever, malaise, stomatitis (mucosal irritation, glossitis, gingivitis
Nursing Considerations
Baseline assessment
- Obtain urinalysis before each dose. If hematuria occurs (greater than 10 RBCs per field), therapy should be withheld until resolution occurs.
- Obtain WBC, platelet count, Hgb before each dose.
- Offer emotional support.
Intervention/evaluation
- Monitor hematologic studies, urinalysis, renal function, LFT.
- Assess for fever, sore throat, signs of local infection, unusual bruising/bleeding from any site, symptoms of anemia (excessive fatigue, weakness).
- Monitor for toxicities.
- Monitor hematopoietic function tests (such as CBC with white cell differential) before therapy and weekly during therapy.
- Assess fluid intake and output.
- Ensure fluid intake of at least 2 L daily to prevent bladder toxicity.
- Monitor urine output for hematuria and hemorrhagic cystitis.
- Administer mesna (protective drug), as indicated and prescribed.
Patient/family teaching
- Alopecia is reversible, but new hair growth may have a different color or texture.
- Do not have immunizations without physician’s approval (drug lowers resistance).
- Avoid contact with those who have recently received live virus vaccine.
- Avoid crowds, those with infections.
- Tell patient to immediately report jaundice, unusual bleeding or bruising, bloody urine, pain on urination, fever, chills, sore throat, cough, difficulty breathing, unusual lumps or masses, mouth sores, or pain in flank, stomach, or joints.
- Instruct patient to maintain adequate hydration and nutrition. Advise him to drink 10 to 12 glasses of fluid each day. (protects against cystitis).
- Advise both male and female patients to use reliable contraception during and immediately after therapy, because drug may cause severe birth defects.
- Urge patient to keep regular follow up appointments for blood tests and monitoring of drug effects.
3.Chlorambucil
| CHLORAMBUCIL |
| Availability: Tablets: 2 mg. |
| Administration/handling: PO: Give 30–60 min before food |
| Before starting therapy, assess for history of seizures or head trauma. After full-course radiation or chemotherapy, wait 4 weeks before giving full doses (because of bone marrow vulnerability). To minimize GI effects, drug may be given at bedtime with antiemetic, especially if high dosage is prescribed |
| Chronic Lymphocytic Leukemia (CLL) : PO: Adults, elderly: 0.1 mg/kg/day for 3–6 weeks or 0.4 mg/kg pulsed doses administered intermittently, biweekly or monthly (increased by 0.1 mg/kg/dose until response/toxicity observed). |
| Hodgkin’s lymphoma (HL): PO: Adults, elderly: 0.2 mg/kg/day for 3–6 wks. |
| Non-hodgkin’s lymphoma (NHL): PO: Adults, elderly: 0.1 mg/kg/day for 3–6 wks. |
| Dosage in Renal Impairment: CrCl 10–50 mL/min: 75% of dose. CrCl less than 10 mL/min: 50% of dose. |
Mechanism of Action:
Inhibits DNA, RNA synthesis by crosslinking with DNA strands.
Therapeutic Effect: Interferes with DNA replication and RNA transcription.
Indications:
- Treatment of chronic lymphocytic leukemia(CLL)
- Hodgkin’s and non-Hodgkin’s lymphomas (NHL).
OFF-LABEL:
- Nephrotic syndrome in children
- Waldenström’s Macroglobulinemia
- Idiopathic membranous nephropathy
- Meningoencephalitis associated with Behçet’s disease
- Rheumatoid arthritis
Cautions & Contraindications:
Hypersensitivity to chlorambucil.
Previous allergic reaction to other alkylating agents, prior resistance to chlorambucil, pregnancy.
Extreme Cautions:
Treatment within 4 weeks after full course radiation therapy or myelosuppressive drug regimen.
Cautions:
History of bone marrow suppression, head trauma, hepatic impairment, nephrotic syndrome, seizure disorder; administration of live vaccines to immunocompromised pts.
Metabolism and Half- Life :
Rapidly, completely absorbed from GI tract. Protein binding: 99%. Metabolized in liver to active metabolite. Not removed by hemodialysis.
Half-life: 1.5 hrs; metabolite, 2.5 hrs.
Drug Interactions:
- May decrease therapeutic effect of BCG (intravesical), vaccines (live).
- May increase adverse effects of vaccines (live).
- May increase myelosuppressive effect of myelo-suppressants (e.g., cladribine).
- Acidic foods, spicy foods may delay absorption.
- May increase serum alkaline phosphatase, AST, uric acid.
Side- Effects:
- Expected: GI effects (nausea, vomiting, anorexia, diarrhea, abdominal distress), generally mild, last less than 24 hrs, occur only if single dose exceeds 20 mg.
- Occasional: Rash, dermatitis, pruritus, oral ulcerations.
- Rare: Alopecia, urticaria, erythema, hyperuricemia
Nursing Considerations
Baseline assessment
Obtain CBC before therapy and weekly during therapy, WBC count 3–4 days following each weekly, CBC during first 3–6 weeks of therapy (4–6 weeks if pt on intermittent dosing schedule).
Intervention/evaluation
- Monitor CBC, serum uric acid, LFT.
- Monitor for hematologic toxicity (fever, sore throat, signs of local infection, unusual bruising/ bleeding from any site), symptoms of anemia (excessive fatigue, weakness).
- Assess skin for rash, pruritus, urticaria
Patient/family teaching
- Increase fluid intake (may protect against hyperuricemia).
- Avoid acidic or spicy foods; may delay absorption of medication.
- Do not have immunizations without physician’s approval (drug lowers resistance).
- Avoid contact with those who have recently received live virus vaccine.
- Promptly report fever, sore throat, signs of local infection, unusual bruising/ bleeding from any site, nausea, vomiting, rash.
- Instruct patient to immediately report unusual bleeding or bruising, fever, nausea, vomiting, rash, chills, sore throat, cough, shortness of breath, seizures, amenorrhea, unusual lumps or masses, flank or stomach pain, joint pain, lip or mouth sores, or yellowing of skin or sclera.
- Tell patient to take drug with full glass of water.
- Inform patient that drug may increase his risk for infection. Advise him to wash hands frequently, wear a mask in public places, and avoid people with infections.
- Advise female patient to use reliable contraception.
4.Melphalan
| MELPHALAN |
| Availability: Injection, Powder for Reconstitution: 50mg. Tablets: (Alkeran): 2 mg. |
| Administration/handling : IV: Reconstitution • Reconstitute 50-mg vial with diluent supplied by manufacturer to yield 5 mg/mL solution. • Further dilute with 0.9% NaCl to final concentration not exceeding 0.45 mg/mL. Rate of administration • Infuse over 15–30 min at rate not to exceed 10 mg/min (total infusion should be administered within 1 hr). Storage • Store at room temperature; protect from light. • Once reconstituted, complete administration within 60 min. |
| PO: Store tablets in refrigerator; protect from light. • Give on empty stomach (1 hr before or 2 hrs after meals). |
| Before starting therapy, obtain CBC with white cell differential and platelet count. Repeat periodically before each Course. For I.V. use, reconstitute by rapidly injecting 10 ml of supplied diluent into vial with lyophilized powder. Shake until solution is clear (yields a concentration of 5 mg/ml). Dilute desired dosage in 0.9% sodium chloride injection to a concentration no greater than 0.45 mg/ml. Administer over 15 minutes, being sure to give entire dose within 60 minutes of reconstitution. Minimize time between reconstitution, dilution, and administration, because solution is unstable. |
| WBC less than 3,000 cells/mm3, platelets less than 100,000 cells/mm3: Withhold treatment until recovery. |
| Ovarian Carcinoma: PO: Adults, elderly: 0.2 mg/kg/day for 5 successive days. Repeat at 4- to 5-wk intervals. |
| Multiple Myeloma (Conditioning before HSCT): IV: Adults, elderly: (Evomela only): 100 mg/m2 daily for 2 days on day 3 and 2 before autologous stem cell transplant on day 0. |
| Multiple Myeloma (Palliative Treatment): PO: Adults: Initially, 6 mg once daily for 2–3 weeks, followed by up to 4 weeks rest, then maintenance dose of 2 mg daily as hematologic recovery begins or 10 mg daily for 7–10 days, then maintenance dose of 2 mg daily (after WBC greater than 4,000 cell/mm3 and platelets greater than 100,000 cells/mm3 titrated to hematologic response or 0.15 mg/kg/day for 7 days with 2–6 weeks rest, then maintenance dose of 0.05 mg/kg/day or 0.25mg/kg/day for 4 days, then repeated at 4- to 6-wk intervals as ANC and platelets return to normal. IV: Adults:16 mg/m2/dose every 2 weeks for 4 doses, then repeat monthly after hematologic recovery. |
Mechanism of Action:
Inhibits DNA and RNA synthesis via carbonium ion formation, cross-links strands of DNA, acts on resting and rapidly dividing tumor cells.
Therapeutic Effect: Disrupts nucleic acid function, producing tumor cell death
Indications:
- Treatment of nonresectable epithelial ovarian carcinoma.
- Palliative treatment of multiple myeloma or high-dose conditioning treatment before hematopoietic stem cell transplantation (HSCT).
OFF-LABEL:
- Hodgkin’s lymphoma, malignant melanoma, neuroblastoma, induction regimen for bone marrow and stem cell transplantation, light chain amyloidosis, Ewing’s sarcoma
Cautions & Contraindications:
- Hypersensitivity to melphalan (Alkeran).
- Resistance to prior melphalan therapy.
Cautions:
Preexisting bone marrow suppression, renal impairment, pregnancy, prior chemotherapy or irradiation.
Metabolism & half- life:
- Oral administration is highly variable. Incomplete intestinal absorption, variable first-pass metabolism, rapid hydrolysis may result.
- Protein binding: 60%–90%.
- Extensively metabolized in blood.
- Eliminated from plasma primarily by chemical hydrolysis.
- Partially excreted in feces; minimal elimination in urine.
- Half- life: PO: 1–1.25 hrs. IV: 1.5 hrs.
Drug Interactions:
- Bone marrow depressants (e.g., cladribine) may increase myelosuppression.
- May decrease the therapeutic effect of BCG (intravesical),vaccines (live).
- May increase adverse effects of natalizumab, vaccines (live).
- May increase serum uric acid.
Side- Effects:
- Frequent: Nausea, vomiting (may be severe with large dose).
- Occasional: Diarrhoea, stomatitis, rash, pruritus, alopecia.
Myelosuppression manifested as hematologic toxicity (principally leukopenia, thrombocytopenia, and, to lesser extent, anaemia, pancytopenia, agranulocytosis). Leukopenia may occur as early as 5 days after drug initiation. WBC, platelet
counts return to normal during 5th week after therapy, but leukopenia, thrombocytopenia may last more than 6 weeks after discontinuing drug. Hyperuricemia noted by haematuria, crystalluria, flank pain.
Nursing Considerations
Baseline assessment
- Obtain CBC, then weekly thereafter. Dosage may be decreased or discontinued if WBC falls below 3,000 cells/mm3 or platelet count falls below 100,000 cells/mm3.
- Antiemetics may be effective in preventing/ treating nausea, vomiting.
Intervention/evaluation
- Monitor CBC with differential, serum electrolytes.
- Monitor for stomatitis.
- Monitor for hematologic toxicity (fever, sore throat, signs of local infection, unusual bruising/ bleeding from any site), symptoms of anaemia (excessive fatigue, weakness), signs of hyperuricemia (haematuria, flank pain).
- Avoid IM injections, rectal temperatures, other traumas that may induce bleeding.
- Monitor patient for thrombocytopenia and leukopenia. If platelet count exceeds 100,000/mm3 or WBC count is below 3,000/mm3, discontinue drug until peripheral blood counts recover.
- Watch closely for indications of bone marrow depression, including infection, anaemia, and bleeding.
- After multiple courses, watch for acute hypersensitivity reaction. If it occurs, discontinue drug and administer volume expanders, corticosteroids, or antihistamines, as prescribed.
- Watch for signs and symptoms of GI or pulmonary toxicity.
- Evaluate renal and hepatic function
Patient/family teaching
- Increase fluid intake (may protect against hyperuricemia).
- Maintain strict oral hygiene.
- Hair loss is reversible, but new hair growth may have different colour, texture.
- Avoid crowds, those with infections.
- Report fever, shortness of breath, cough, sore throat, bleeding, unusual bruising.
- May suppress ovarian function, leading to amenorrhea.
- Tell patient to take oral tablets without food, because food may decrease drug absorption.
- Instruct patient to take entire daily oral dose at one time on empty stomach.
- Advise patient to immediately report unusual bleeding or bruising, fever, chills, sore throat, shortness of breath, yellowing of skin or eyes, persistent cough, flank or stomach pain, joint pain, black tarry stools, rash, or unusual lumps or masses.
- Tell patient to consult prescriber before using over-the-counter medications.
- Advise patient to use reliable contraception.
- Caution patient to avoid breastfeeding
5.Bendamustine
| BENDAMUSTINE |
| Availability: Injection, Powder for Reconstitution: (Treanda): 25 mg, 100 mg. Injection: (Bendeka): 100 mg/4 mL. |
| ADMINISTRATION/HANDLING : IV: Reconstitution • Reconstitute each 100-mg vial with 20 mL Sterile Water for Injection (25-mg vial with 5 mL) for final concentration of 5 mg/mL. • Powder should completely dissolve in 5 min. Discard if particulate matter is observed. • Withdraw volume needed for required dose (based on 5 mg/mL concentration) and immediately transfer to 500-mL infusion bag of 0.9% NaCl for final concentration of 0.2–0.6 mg/mL. Reconstituted solution must be transferred to infusion bag within 30 min of reconstitution. • After transferring, thoroughly mix contents of infusion bag. Rate of administration • Infuse over 30 min for CLL or 60 min for NHL. Storage • Reconstituted solution should appear clear and colourless to pale yellow. Final solution is stable for 24 hrs if refrigerated or 3 hrs at room temperature. • Administration must be completed within these stability time frames. |
| Stay alert for infusion reactions. Signs and symptoms include fever, chills, pruritus, and rash. Rarely, severe anaphylactic and anaphylactoid reactions have occurred. Monitor patient and discontinue drug if severe reaction arises. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles if patient had previous infusion reaction. Check I.V. site frequently to avoid extravasation. |
| Antiemetics are recommended to prevent nausea and vomiting. |
| Chronic Lymphocytic Leukaemia : IV infusion: Adults/elderly: 100 mg/m2 given over 30 min daily on days 1 and 2 of a 28-day cycle as a single agent, up to 6 cycles. |
| Non-Hodgkin’s Lymphoma: IV infusion: Adults/elderly: 120 mg/m2 on days 1 and 2 of a 21-day cycle as a single agent, up to 8 cycles |
| Dose Modification: Hematologic toxicity Grade 4 or greater: Withhold until ANC 1,000 cells/mm3 or greater, platelet 75,000 cells/mm3 or greater. CLL: toxicity Grade 3 or greater: Reduce dose to 50 mg/m2 on days 1 and 2 of each treatment cycle. Recurrence: Reduce dose to 25 mg/2 on days 1 and 2 of each cycle. NHL: hematologic toxicity Grade 4 or nonhematologic toxicity Grade 3 or greater: Reduce dose to 90 mg/m2 on days 1 and 2 of each cycle. Recurrence: Reduce dose to 60 mg/ m2 on days 1 and 2 of each treatment cycle. |
| Dosage in Renal Impairment : Not recommended in pts with CrCl less than 40 mL/min |
Mechanism of Action:
Alkylates and cross-links double-stranded DNA.
Therapeutic Effect: Inhibits tumour cell growth, causes cell death.
Indications:
- Treatment of chronic lymphocytic leukaemia (CLL).
- Treatment of indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab- containing regimen.
OFF-LABEL:
- Treatment of mantle cell lymphoma
- Relapsed multiple myeloma.
- First-line treatment for follicular lymphoma
- Treatment of Waldenström’s macroglobulinemia.
Cautions & Contraindications:
- Hypersensitivity to bendamustine.
- (Bendeka only): polyethylene glycol 400, or propylene glycol monothioglycerol.
Cautions:
Myelosuppression (may increase risk of infection), renal/hepatic impairment, dehydration, HF.
Metabolism and Half- Life:
Metabolized via hydrolysis to metabolites.
Protein binding: 64%–95%. Excreted primarily in faeces. Half-life: 40 min.
Drug Interactions:
- May decrease therapeutic effect of BCG (intravesical).
- May increase serum AST, bilirubin, creatinine, glucose, uric acid.
- May decrease WBCs, neutrophils, Hgb, platelets; serum potassium, sodium, calcium.
Side – Effects:
- Frequent (24%–16%): Fever, nausea, vomiting.
- Occasional (9%–8%): Diarrhoea, fatigue, asthenia (loss of strength, energy), rash, decreased weight, nasopharyngitis.
- Rare (6%–3%): Chills, pruritus, cough, herpes simplex infecti
Nursing Considerations
Baseline assessment
- Obtain baseline CBC, BMP, LFT before treatment begins and routinely thereafter.
- Question for possibility of pregnancy.
- Offer emotional support.
Intervention/evaluation
- Offer antiemetics to control nausea, vomiting.
- Monitor daily pattern of bowel activity, stool consistency.
- Assess skin for evidence of rash.
- Monitor for signs of infection (fever, chills, cough, flu-like symptoms).
- Monitor for hypertension.
- Hematologic nadirs occur in 3rd week of therapy and may require dose delays if recovery to recommended values has not occurred by day 28.
- Closely monitor complete blood count with differential and renal and hepatic function test results.
- Monitor for skin reactions, including rash, toxic reactions, and bullous exanthema. Such reactions may be progressive and worsen with further treatment. In severe or progressive skin reaction, withhold or discontinue drug.
- Watch for tumor lysis syndrome, especially during first treatment cycle. Signs and symptoms include irregular heartbeat, shortness of breath, high potassium level, high uric acid level, and impaired mental ability.
- Without intervention, acute renal failure and death may occur. Take preventive measures, as ordered, including maintaining adequate volume status, close monitoring of blood chemistry, and allopurinol administration during first 2 weeks of therapy in high-risk patients. However, be aware that concomitant use of allopurinol may increase risk of severe skin toxicity.
Patient/family teaching
- Avoid crowds, those with known infection.
- Avoid contact with anyone who recently received live virus vaccine.
- Do not have immunizations without physician’s approval (drug lowers body resistance).
- Promptly report fever, chills, flu-like symptoms, sore throat, unusual bruising/bleeding from any site.
- Male pts should be warned of potential risk to their reproductive capacities.
- Inform patient that drug may increase risk of infection. Advise patient to wash hands frequently, wear mask in public places, and avoid people with infections.
- Advise female that drug may harm fetus; caution her to avoid becoming pregnant. If patient is pregnant during therapy or becomes pregnant, inform her of risk to fetus
REFERENCES
- Robert Kizior, Keith Hodgson, Saunders Nursing Drug handbook,1st edition 2024, Elsevier Publications. ISBN-9780443116070
- McGraw Hill- Drug Handbook, Seventh Edition, 2013, McGraw Hill Education Publications,9780071799430.
- April Hazard, Cynthia Sanoski, Davi’s Drug Guide for Nurses -Sixteenth Edition 2019, FA Davis Company Publications,9780803669451.
- Jones and Bartlet, Pharmacology for Nurses, Second Edition, 2020, Jones and Bartlet Learning Publications, ISBN 9781284141986.
- Nursebro.com, Search – Nursebro
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