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Patient Management

Safety Summary

The safety of single-agent NAVELBINE (vinorelbine tartrate) Injection has been carefully assessed in a large database (365 patients). Granulocytopenia is the dose-limiting toxicity associated with NAVELBINE. As with other cancer chemotherapy, infections and sepsis may occur and can be life-threatening. In clinical studies, granulocytopenia resulted in hospitalizations for fever and/or sepsis in 8% of patients. Septic deaths occurred in approximately 1% of patients.

Nonhematologic adverse effects are usually mild or moderate and include injection site reactions (38%), nausea (34%)/vomiting (15%), constipation (29%), fatigue (27%), peripheral neuropathy (20%), diarrhea (13%), and alopecia (12%). Asthenia and injection site reactions are the only nonhematologic Grade 3-4 adverse events that occurred in greater than 5% of patients. Severe dyspnea was observed in 2% of patients. Since NAVELBINE is a moderate vesicant, proper administration technique is important to avoid potential extravasation. Leakage into tissue may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately and appropriate measures taken.

Patients treated with NAVELBINE usually do not require routine pretreatment with antiemetics or support with growth factors. Growth factors may be administered at recommended doses starting 24 hours after administration of NAVELBINE. Growth factors should not be administered during the 24 hours before NAVELBINE administration. The combination of cisplatin and NAVELBINE results in higher incidences of severe nausea, vomiting, alopecia, and ototoxicity than NAVELBINE monotherapy. (Note: These toxicities are commonly associated with cisplatin.) The incidence of granulocytopenia is higher in patients receiving combination therapy with NAVELBINE and cisplatin as compared to NAVELBINE as a single agent, but the incidence of neurotoxicity is not increased. As with other vinca alkaloids, the use of NAVELBINE with mitomycin may result in pulmonary reactions.

Nursing Care Plan

Table 1 provides recommendations for preventing or coping with common adverse effects associated with NAVELBINE (vinorelbine tartrate) Injection.


Table 1. Nursing Care Plan for the Most Common Side Effects associated with NAVELBINE (vinorelbine tartrate) Injection

1.
Potential Nursing Diagnoses

High risk for infection related to treatment with a myelosuppressive chemotherapy agent

Outcome Criteria

The Patient will:
(a) demonstrate knowledge of risk factors with potential for infection and will practice precautions to prevent infection
(b) be free from complications of myelosuppression
(c) cite whom to call should he/she develop fever or other sign of infection

Intervention

1. Teach patient and family the following: a) general principles of chemotherapy; b) signs and symptoms of injection; c) appropriate practices to prevent infection
2. Due to sharp drop and rapid recovery of WBCs, monitor CBC on day of treatment, prior to treatment, weekly during treatment, and as indicated
3. Verify dose calculation is correct and is based on criteria for dose modifications for patients with hematologic toxicity or hepatic insufficiency
4. Asses patient for additional risk factors which may place the patient at higher risk for infection (e.g., presence of VAD*,patients who have been heavily pretreated and have low bone marrow reserve, etc)
5. Monitor the patient for clinical manifestationsof infection (local and systemic) when WBC less than 1000 cells/cubic mm and absolute granulocyte count less than 500 cells/cubic mm
6. Advise patient to call physician or other on-call health physician immediately for symptoms of infection or fever greater than 101 degrees F
*venous access device


2.
Potential Nursing Diagnoses

Potential for impaired skin integrity or pain at injection site (vein inflammation or extravasation into tissues related to chemical vesicant and irritant)

Outcome Criteria

The Patient will be free from complications of administration of a vesicant/irritant

Intervention

1. NAVELBINE may be administered via a carefully selected peripheral intravenous line (IV) or a VAD*. The drug should be administered over no more than 6 to 10 minutes and the line should be flushed with at least 100mL of fluids after administration. Risk of venous complications is greater if the infusion/injection is greater than 10 minutes
2. Prior to initating treatment, instruct the patient to report immediately any symptoms at the site such as pain, burning, stinging, or swelling
3. Educate the patient and family concerning the potential for the drug to cause venous irritation, pain, phlebitis and even tissue damage if extravasated. Remind them of the rationale for the importance of reporting the above symptoms during infusion
4. Assess IV site frequently during administration for patency, swelling, and erythema. Assess for discomfort or other unusual signs and symptoms at site during and after infusion, as indicated
5. If extravasation is suspected, stop the infusion and follow institutional guidelines. The ONS Chemotherapy Guidelines 4 proviede additional recommendations for the prevention of extravasation injuries
*venous access device


3.
Potential Nursing Diagnoses

Weakness and fatigue

Outcome Criteria

The patient will:
(a) share feelings regarding the effects of fatigue and weakness on his/her life
(b) establish priorities for daily and weekly activities that stimulate and balance physical, cognitive, affective, and social domains

Intervention

1. Assist patient to identify energy patterns, strengths, and abilities. Assist them to recognize the need to schedule activities, set realistic goals (from the patient's perspective), priorities, delegate tasks, and acknowledge limitations
2. Educate patient and family on causes of fatigue and to view fatigue as a normal part of treatment rather than a sign of debilitation related to the disease
3. Engage family and friends into accepting delegated tasks, as appropriate
4. Assess degree of fatigue, and exacerbating and relieving factors. Minimize, if possible, exacerbating factors. A fatigue assessment scale may be used, much like the one for pain: 1-10 (1 rating = none; 10 = worst possible). Have the patient characterize the fatigue and weakness in his/her words


4.
Potential Nursing Diagnoses

Constipation

Outcome Criteria

The patient will:
(a) describe methods to prevent constipation
(b) describe factors that contribute to constipation
(c) demonstrate regular and/or improved bowel elimination and incorporate an effective bowel regimen in his/her daily routine

Intervention

1. Assess patient's normal bowel elimination pattern prior to beginning treatment and before each subsequent treatment
2. Educate patient on the potential for NAVELBINE to cause altered elimination patterns and teach him/her the importance of maintaining a regular bowel elimination pattern
3. Teach patient interventions to promote regular bowel elimination: a) adequate fluid intake (3 L/day); b) high-fiber and bulky food intake; c) exercise/mobility; and d) stool softeners and laxatives
4. Establish an individual plan with each patient, based on his/her risk factors, to move bowels either once a day or every other day. Advise them to contact their physician or other healthcare provider on-call for problems with constipation or obstipation. Instruct them to report promptly complaints of acute abdominal pain
5. Assess for other factors which may contribute to constipation, such as regular use of narcotics for cancer-related pain, or decreased mobility

5.
Potential Nursing Diagnoses

Altered comfort related to the effects of chemotherapy on the vomiting center, as evidenced by complaints of nausea, vomiting, and/or anorexia

Outcome Criteria

The patient will:
(a) report a decrease in nausea and vomiting
(b) describe and perform relief measures during episodes of nausea, vomiting, or anorexia

Intervention

1. Educate the patient and family that nausea and vomiting may occur with treatment but usually the symptoms are mild to moderate, if they occur. Remind them medication can be given to alleviate these sympoms
2. Assess need for prophylactic antiemetic. Due to the low incidence of severe nausea and vomiting with single-agent NAVELBINE, the use of serotonin antagonists is generally not required
3. If NAVELBINE is being given in combination with cisplatin, adjust the antiemetic schedule as appropriate. A more intensive antiemetic regimen will be necessary
4. Encourage frequent small meals (six per day plus snacks) to reduce the feeling of distended stomach
5. For patients with nutritional deficits or obvious gastrointestinal difficulties, refer patient to the dietician for additional information and assistance
6. Educate patient about other interventions that have been reported to control nausea and stimulate eating (eating foods at room temperature, eating ice chips, avoiding offensive odors, eating what sounds appealing, etc.)
7. Prior to each treatment, assess how well the patient tolerated the prior treatment and modify the antiemetic regimen if needed
8. Make referrals, as appropriate, to other health professionals when it appears patient may benifit from behavior modification techniques (guided imagery. relaxation, therapeutic touch. etc.)


6.
Potential Nursing Diagnoses

Sensory/perceptual alterations-(jaw pain, tumor pain, peripheral neoropathy, and paresthesias)

Outcome Criteria

The patient will:
(a) be free from complications of neurotoxicity
(b) be free from discomfort and dysfunction
(c) cite signs and symptoms of neurotoxicity that should be reported

Intervention

1. Assess patient for sensory or perceptual alterations, hyporeflexia, or motor difficulties prior to treatment. Patient with preexxisting neurologic deficits may not be candidates for NAVELBINE depending on the physician's clinical judgment. Patients at high risk for developing neurologic complications include patients who have received previous neurotoxic chemotherapy agents
2. Monitor high-risk patients closely. For all patients, prior to each subsequent treatment, perform a brief neurological examination to identify any clinical changes. If any significant changes are noted, notify treating physician before NAVELBINE treatment
3. Educate the patient and family that the treatment with NAVELBINE has a small potential to cause numbness and tingling in fingers and toes, weakness in feet, legs, and hands, and difficulty distinguishing temperature changes in extreminities, and diminished reflexes. Inform patient that other neuropathies, including ocular complications, have been reported with vinca alkaloids, but not with NAVELBINE
4. Advise the patient to report any of the the above alterations or symptoms to his/her treating physician or other health care provider on call

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