AEs (≥20% in any group)6
These measures may reduce the need for dose reductions, delays, interruptions or early treatment discontinuations, thereby optimising clinical benefit obtained from SUTENT.
This guidance provides advice to support you in the prevention, identification and treatment of common AEs associated with SUTENT, with the aim of reducing their severity and improving treatment tolerability.
Please see the SUTENT® Summary of Product Characteristics for Great Britain or the SUTENT® Summary of Product Characteristics for Northern Ireland for full safety information.
Signs and Symptoms | Assessment |
---|---|
Damage to the mouth area, such as bleeding gums and mouth ulcers4,5 | Check if your patient is using any concomitant medicines |
General sensitivity in the mouth or alterations to taste6 | Assess and stabilise comorbidities7 |
Experiencing pain, particularly when brushing teeth or eating5 | Assess the severity of stomatitis8 |
Do you get more mouth ulcers than usual?
More pronounced on the feet of active people and in hot climates4
Before starting SUTENT therapy, help patients to minimise risk/severity of hand–foot skin reactions by encouraging them to:4,10,11
Visit a chiropodist prior to beginning SUTENT therapy for a podiatry review and to remove calluses
Grading and treating hand–foot skin reactions6,8
Signs and Symptoms | Assessment |
---|---|
Hand–foot skin reactions usually occur on the palms of hands and soles of feet, but may affect other areas | Check if your patient is using any concomitant medicines |
Look for red, swollen and sensitive skin, tingling sensation or numbness, and blisters, cracks and peeling4,6,10 | Assess and stabilise comorbidities7 |
Can you hold a cup of tea? Is wearing shoes unbearable? How have the changes to your skin affected what you can do?
Are you noticing any skin changes, such as change in colour, feel or sensation?
Do you have any skin changes in other areas?
How does your hand–foot skin reaction affect your everyday life?
Reinforce preventative advice to patients who suffer from hand–foot skin reactions and further encourage patients to:4,6,10
Relief from symptoms can be found using:6,10
Some patients may require a SUTENT dose adjustment or treatment break based on the severity of hand–foot skin reactions4. The severity of hand–foot skin reactions needs to be weighed up against the benefits of maintaining the recommended SUTENT dose. Once hand–foot skin reactions have resolved, consider re-initiating SUTENT treatment at 50 mg daily.7
If a patient believed to have hand–foot skin reactions does not respond to dose interruption or dose reduction, then other diagnoses must be considered.6
Grade | Characteristics | Strategy |
---|---|---|
1 | Minimal skin changes or dermatitis (e.g. erythema, oedema or hyperkeratosis) without pain. | Continue at same dose level. Treat with emollient creams and encourage measures to avoid skin irritation. |
2 | Skin changes (e.g. peeling, blisters, bleeding, oedema or hyperkeratosis) with pain that limits instrumental activities of daily living. | Treat with emollient creams and encourage measures to avoid skin irritation. Consider a SUTENT dose reduction. |
3 | Severe skin changes (e.g. peeling, blisters, bleeding, oedema or hyperkeratosis) with pain that limits self-care activities of daily living. | Consider a SUTENT dose reduction or treatment break until grade ≤1, then resume treatment at reduced dose. |
Hypertension has been proposed as a potential biomarker for SUTENT efficacy, so treatment should be maintained at the recommended dose when possible.16,17
Cardiovascular AEs
Hypertension
Advise your patients to report any of the following AEs directly and urgently, they should not wait for their next scheduled appointment:
Have you taken your blood pressure this week?
Have you felt short of breath, very tired or had any swelling of the hands and feet since taking SUTENT?
Have you had a persistent headache or felt any dizziness since taking SUTENT?
Reinforce preventative advice and further encourage patients to consider non-pharmacological measures in the first instance12. Some patients may require SUTENT dose adjustment or treatment break based on severity of their cardiovascular AEs/hypertension2,5,14. The severity of their cardiovascular AEs should be weighed up against the benefits of maintaining the recommended SUTENT dosing schedule.
Cardiovascular AEs
Hypertension
If prescribed, antihypertensive treatment may need to be reduced during off-treatment periods and stopped altogether when not taking SUTENT, to prevent postural hypotension.4
Grade | Characteristics | Strategy |
---|---|---|
1 | Prehypertension (systolic BP 120-139 mmHg or diastolic BP 80–89 mmHg) | Continue at same dose level |
2 | Stage 1 hypertension (systolic BP 140–159 mmHg or diastolic BP 90–99 mmHg); medical intervention indicated; recurrent or persistent (≥24 hours); symptomatic increase by >20 mmHg (diastolic) or to >140/90 mmHg if previously within normal limit; monotherapy indicated. |
Continue at same dose level, except in the presence of:
|
3 | Stage 2 hypertension (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg); medical intervention indicated; more than one drug or more intensive therapy than previously used/indicated. | Interrupt SUTENT therapy until grade ≤1 or return to baseline. Resume at -1 dose level. |
4 | Life-threatening consequences (e.g. malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis); urgent intervention indicated | Discontinue |
Gastrointestinal AEs may include constipation, diarrhoea, indigestion, bloating, swallowing difficulties, nausea or vomiting and discomfort or bleeding in the mouth or rectum.2,4,6,12
Before starting SUTENT therapy, help patients to minimise the risk and severity of gastrointestinal AEs by encouraging them to:
Weight loss has been observed and can be a symptom of loss of appetite, generally caused by altered taste, tender mouth or indigestion4. Symptoms generally resolve after a week off treatment, but weight loss can be treatment-limiting4.
Have you suffered from a loss of appetite since starting treatment? Why do you think this might be?
Have you experienced any increase in indigestion, diarrhoea, constipation or flatulence since starting treatment?
Have you felt nauseous or been sick since starting treatment?
Patient education regarding nutrition and consultation with a dietician is recommended6. SUTENT dose interruptions/ reductions from the recommended 50 mg daily dosing can be avoided or minimised using therapy management, helping patients to gain optimal benefit6. Reinforce preventative advice and provide supporting advice to patients if they suffer from gastrointestinal AEs.
Encourage patients to:
Nausea Grading | Effect |
---|---|
Grade 1 | Loss of appetite without alteration in eating habits |
Grade 2 | Oral intake decreased without significant weight loss, dehydration or malnutrition |
Grade 3 | Inadequate oral caloric or fluid intake; tube feeding, total parenteral nutrition or hospitalisation indicated |
Vomiting Grading | Effect |
---|---|
Grade 1 | 1–2 episodes (separated by 5 minutes) in 24 hours |
Grade 2 | 3–5 episodes (separated by 5 minutes) in 24 hours |
Grade 3 | ≥6 episodes (separated by 5 minutes) in 24 hours; tube feeding, total parenteral |
Grade 4 |
Life-threatening consequences; urgent intervention indicated |
Encourage patients to:
Diarrhoea Grading | Effect |
---|---|
Grade 1 | Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline |
Grade 2 | Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared to baseline |
Grade 3 | Increase of ≥7 stools per day over baseline; incontinence; hospitalisation indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living |
Grade 4 | Life-threatening consequences; urgent intervention indicated |
Management strategies for diarrhoea | |
---|---|
Grades | Strategy |
1 & 2 | Continue at same dose level. Oral hydration in small amounts at a time + anti-diarrhoeal medications |
3 & 4 | Increase of ≥7 stools per day over baseline; incontinence; hospitalisation indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living |
Other gastrointestinal disorders treatment options:
Blood disorders/dyscrasias such as neutropenia, thrombocytopenia, anemia and leukopenia have been associated with SUTENT treatment.2
Before starting SUTENT, advise patients on:
Carry out a complete blood count to assess for blood disorders and abnormal blood counts2,18
Have you felt ill or had a temperature recently?
Are you bruising or bleeding more easily than normal?
Have you been very tired recently, had any breathlessness, had faster heart rate than normal, experienced rushing sounds in the ears, been feeling faint, experienced headaches or had pale skin?
How do the blood disorders affect your everyday life?
Provide supporting advice to patients with blood disorders.
Neutropenia
Typically, the neutropenia associated with SUTENT treatment requires no intervention - blood counts tend to recover during the 2-week treatment break between cycles.5,6
Anemia
Grade 3/4 anemia usually does not require dose modification, but should be treated with iron supplementation or blood transfusions if severe or life threatening. Erythropoietin-stimulating agents should be used with caution owing to potential risks and toxicities associated with these drugs.5,6
Management strategies for blood disorders | |
---|---|
Grade | Strategy |
1 & 2 | Continue at same dose level |
2 | Withhold dose. When grade ≤2, resume treatment at original dose* |
3 | Withhold dose. When grade ≤2, resume treatment at -1 dose level* |
Recurring grade 3/4 neutropenia or thrombocytopenia persisting for at least 5 days and/or neutropenic fever/bleeding signs may require dose/schedule changes. 6
Grading Neutropaenia | |
---|---|
Grade | Strategy |
1 | ANC ≥1.5 to <2.0 x 109/L |
2 | ANC ≥1.0 to <1.5 x 109/L |
3 | ANC ≥0.5 to <1.0 x 109/L |
4 |
ANC <0.5 x 109/L |
Includes conditions such as hand– foot skin reactions, rash, dry skin, nail modifications and skin/hair discolouration.2,6 This often occurs within the first 6 weeks of treatment (typically in Weeks 3 and 4).6
Inform patients of the potential for reversible depigmentation of the hair and skin. Patients should avoid hot showers, use sun protection and wear loose-fitting cotton clothes6. Before starting SUTENT therapy, help patients to minimise risk/severity of skin and hair changes – encourage them to:6,7
Are you noticing any skin or hair changes, such as change in colour, feel or sensation?
How are you managing your skin and hair changes? Do they affect your everyday life?
Provide supporting advice to patients if they suffer from skin and hair changes
Patients with dry skin/rash:4,6,12
Patients with severe genital rash should be referred to a dermatologist who can prescribe an appropriate treatment after ruling out a yeast or bacterial infection.
The severity of the skin and hair changes need to be weighed up against the benefits of maintaining the recommended SUTENT dosing schedule.
Grading for rashes | |
---|---|
Grade | Appearance |
1 | Macules/papules covering <10% body surface area with or without symptoms (e.g. pruritus, burning, tightness). |
2 | Macules/papules covering 10–30% body surface area with or without symptoms (e.g. pruritus, burning, tightness) that limit instrumental activities of daily living. |
3 | Macules/papules covering >30% body surface area with or without associated symptoms that limit self-care activities of daily living. |
Check for underlying factors that may cause fatigue such as hypothyroidism, anaemia, depression, dehydration, poor diet, lack of exercise, pain, insomnia, chronic illness and appetite.4,18
Fatigue
Typically manifests early, within days or weeks of SUTENT treatment initiation18. May be transient, resolving as the patient responds to treatment12. Can be treatment-related as SUTENT can cause hypothyroidism or anaemia, which result in fatigue2,23
Hypothyroidsim
Is often under-diagnosed and may be the underlying cause of fatigue2,4,23. Typically takes time to manifest (usually months), although occasionally the time of onset can be within weeks of SUTENT treatment initiation4,6.
Fatigue
Changes in your patient’s activities and attentiveness on the phone or in the clinic4.
Hypothyroidism
Symptoms of hypothyroidism include4:
Check for underlying factors that may cause fatigue such as hypothyroidism, anaemia, depression, dehydration, poor diet, lack of exercise, pain, insomnia, chronic illness and appetite.4,18
Have you been feeling more tired than usual since you started taking SUTENT?
Do you do any exercise?
At what time of the day do you take SUTENT?
How does your fatigue and/or hypothyroidism affect your everyday life?
Patients may require SUTENT dose adjustment or treatment break based on severity of fatigue/hypothyroidism6. Severity of the symptoms need to be weighed up against the benefits of maintaining the recommended SUTENT dosing schedule.
Kollmannsberger C, et al. Oncologist 2011;16:543–553.
Fatigue
Determine if fatigue is disease or drug-related6. Alternative causes for fatigue should be ruled out – fatigue may be exacerbated by dehydration, hypercalcaemia, anaemia or depression6. Reinforce preventative advice and further encourage patients to:
Hypothyroidism
Management strategies for hypothyroidism | |
---|---|
Grade | Strategy |
1 | Asymptomatic – clinical or diagnostic observations only |
2 | Symptomatic |
3 | Severe symptoms, hospitalisation |
4 | Life-threatening consequences Overt hypothyroidism, defined as elevated TSH and a low T4 level, can be treated with thyroid hormone replacement. |
References
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