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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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The content of this website has been produced in line with the INLYTA® (axitinib​​​​​​​) Summary of Product Characteristics for Great Britain. 
​​​​​​​
Prescribing Information for INLYTA® (axitinib) click here.  Adverse event reporting information can be found at the bottom of the page.

Safety 

​​​​​​​​​​​​​INLYTA® has a well-characterised safety and tolerability profile.1-5

A total of 4% of patients discontinued treatment with INLYTA due to AEs in a PHASE III clinical trial with INLYTA® monotherapy.2

Clinicians' real-world experience of INLYTA® complements the safety and tolerability profile of INLYTA® observed in clinical trials.1-5
 
Proactive side-effect management can help optimise outcomes with INLYTA®.
6

Patients should be educated about the potential occurrence of side effects and how to recognise and manage them.6

If side effects remain unresolved despite active side-effect management, reducing the INLYTA® dose to 3 mg BD or 2 mg BD can be considered.1,6
 
Please see the Summary of Product Characteristics for full safety information.  

What to Look For:
Hypertension is defined as:7,8

•​​​​​​​ Systolic BP >140 mmHg and
• Diastolic BP >90 mmHg 

Hypertension of all grades (as defined by NCI-CTCAE version 3.015) was reported in 40% of patients on INLYTA® in the Phase III AXIS study2

• Hypertension of Grade 3 or above was reported in 16% of patients2

Hypertension that develops while receiving INLYTA® has been proposed as a biomarker for the anti-tumour effects of INLYTA®6
The median onset time for hypertension was within the first month of initiating INLYTA® therapy1
​​​​​​​
• BP elevations were observed as early as 4 days after starting INLYTA®.1
​​​​​​​
Prevention: 
Measure baseline BP before initiating treatment.9 BP should be well-controlled before starting INLYTA®1,6,10

• Actively treat towards a target BP of ≤140/90 mmHg using standard antihypertensive medications10
• Consider different BP goals in some patients (e.g. those who have pre-existing cardiovascular risk factors)6,10,11 or via their GP or community HCP

Advise patients that BP levels may increase following the start of INLYTA®. Encourage patients and family members/ caregiver to measure BP at home6,10,11

If monitoring at home:
• Show patients how to measure BP correctly, including the proper fitting of the cuff6
• Provide individualised thresholds for contacting their clinician6

As well as home monitoring, schedule regular HCP visits to measure BP every two weeks during the first three months of therapy and monthly thereafter.2 It may be appropriate to encourage patients to make healthy lifestyle choices, including:7
• Weight control
• Regular exercise
• Moderate alcohol consumption
• Change in diet, including reduced salt and fat intake, and increased fruit and vegetable consumption
 
Signs and Symptoms: 
Hypertension is usually asymptomatic but may manifest as:7
• Persistent headache
• Dizziness
• Pallor

Advise your patients to report any of the above signs and symptoms to you immediately. They should ring the clinic and not wait for their next hospital appointment

Assessment:  
Take a patients full medical history to check concomitant medications and comorbidities before initiating treatment6

• Screen for hypertension and stabilise BP before starting INLYTA®1,11
• Assess severity of hypertension as its impact may differ from patient to patient (see Table 1 for grading)7,8
 
Questions for your patients:  
• Have you checked your BP this week?
Encourage your patients to monitor their BP either at home or via their GP
or community HCP and keep a diary of their readings

• Have you had a persistent headache or felt any dizziness since
taking INLYTA®?
These symptoms may be indicative of hypertension and will require
urgent attention
 
Management
Patients with hypertension (without type 2 diabetes) should be treated as needed with standard antihypertensive medication1,6,10,11 (see Figure for treatment recommendation7)

Hypertension treatment recommendations​​​​​​​

Adapted from NICE Guidance 136. August 2019. *Choose a low-cost ARB; † a CCB is preferred but consider a thiazide-like diuretic if a CCB is not tolerated or the person has oedema, evidence of heart failure or a high risk of heart failure; ‡ consider a low dose of spironolactone; § or higher doses of a thiazide-like diuretic; § at the time of publication (August 2019), spironolactone did not have a UK marketing authorisation for this indication. Informed consent should be obtained and documented; ¶consider an alpha- or beta-blocker if further diuretic therapy is not tolerated or is contraindicated or ineffective

Antihypertensive agents should be selected according to patient comorbidities, drug interactions and contraindications11

Angiotensin-converting enzyme inhibitors and dihydropyridine calcium channel blockers are preferred treatment options for targeted agent-associated hypertension, followed by diuretics and ß-blockers7

• Non-dihydropyridine calcium channel blockers (e.g. verapamil and diltiazem) are CYP3A4/5 inhibitors and may increase INLYTA® plasma levels. Selection of alternative antihypertensive medicines with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, a dose decreases of INLYTA® to approximately half the dose is recommended1

Grading Hypertension12

Grade

Characteristics

1 (mild)

• Clinic BP ≥140/90 mmHg and
• ABPM daytime average or
• HBPM average BP ≥135/85 mmHg 

2 (moderate)

•  Clinic BP ≥160/100 mmHg and
​​​​​​​• ABPM daytime average or 
• HBPM  average BP ≥150/95 mmHg

3 (severe)

•  Clinic systolic BP ≥180 mmHg or 
•  Clinic diastolic BP ≥110 mmHg

ABPM= ambulatory blood pressure monitoring; BP=blood pressure; HBPM=home blood pressure monitoring

The severity of hypertension needs to be weighed up against the benefits of maintaining INLYTA® therapy.9

In persistent hypertension, despite using antihypertensive medicinal products, INLYTA® dose should be reduced (see Table 2 for management recommendations).1

A diagnostic brain magnetic resonance image should be considered in case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome.1

Management Strategies for Hypertension6
​​​​​​​

Grade

Strategy

1 (mild)

Continue at the same dose
​​​​​​​• Initiate or intensify existing antihypertensive therapy

2 (moderate)

Consider dose reduction
• Intensify existing antihypertensive therapy

3 (severe)

Temporarily interrupt INLYTA® therapy and monitor for hypotension in patients receiving antihypertensive therapy
​​​​​​​
• Once the patient is normotensive, resume INLYTA® at a reduced dose level
• Intensify existing antihypertensive therapy

Hypertension

Dysphonia

What to Look For:
Disorders of the voice, characterised by altered vocal quality, pitch, loudness or
vocal effort that impairs communication13

Dysphonia of Grade 1/2 was reported in 31% of patients on INLYTA® in the Phase III
AXIS study
2
• No dysphonia of Grade 3 or above was reported

Prevention:
Encourage patients to keep hydrated and avoid irritants, such as smoking13

Advise patients that they may experience hoarseness once INLYTA therapy begins but that it is usually mild and reversible.

Signs and Symptoms: 

• Persisting sensation of a lump in throat13
• Difficulty or pain with swallowing13
• Sore throat13
• Chronic throat clearing and coughing13
• Weak, hoarse, rough or harsh voice6
​​​​​​​
Assessment:  
Confirm the presence of dysphonia through voice-specific questions and physical examination13

Voice-specific questions include:13

• Does it take more effort to use your voice?
• What is different about the sound of your voice?
• Do you have a difficult time getting loud or projecting?
• Have you noticed changes in your pitch or range?

Assess severity of dysphonia as its impact may differ from patient to patient13

Questions for your patients  

• Have you experienced a sore throat or hoarseness since you started taking INLYTA®?
These symptoms may be indicative of dysphonia and will require assessment and possible treatment


• Has your hoarseness persisted for three months or longer?
Patients should be referred to an ear, nose and throat specialist if their hoarseness persists or if a serious underlying cause for their dysphonia is suspected


• How are the symptoms of dysphonia affecting your everyday life?
The severity and impact of dysphonia may differ from patient to patient
 
Management
Dysphonia is intermittent with INLYTA® treatment
6, and usually resolves rapidly following a 1–2-day treatment interruption
• Physical examination of the head and neck is recommended if hoarseness persists13

Encourage patients to:

• Drink ample water13
• Avoid irritants, such as tobacco smoke13
• Limit voice strain13
• Use lozenges6
​​​​​​​
Consider a dose reduction if dysphonia is severe for the patient10

Grading Dysphonia14
Assessment of the patient's voice - can be done through a simple scale:​​​

Grade

Characteristic

1

Subjectively normal voice

2

Mild dysphonia

3

Moderate dysphonia

4

Severe dysphonia

5

Aphonic (with use of additional qualifiers used as necessary - for example, breathy, strained)

Grade

Characteristics

1

Mild or intermittent hoarseness or voice change, but fully understandable

2

• Moderate or persistent voice changes
• It may require occasional repetition but understandable on the telephone

3

• Severe voice changes, including predominantly whispered speech
• May require frequent repetition or face-to-face
contact for understandability
• Requires voice aid for ≤50% of communication

4

• Disabling, non-understandable voice or aphonic
• Requires voice aid for >50% of communication or
requires >50% written communication

Hand-foot syndrome

What to look for 
Hand-foot skin reactions (palmar-plantar erythrodysesthesia) are characterised by redness and swelling of the palms of the hands or soles of the feet15

•​​​​​​​ They are distinct from chemotherapy-related hand-foot skin reactions15

Hand-foot skin reactions of all grades were reported in 27% of patients on INLYTA® in the Phase III AXIS study2

• Hand-foot skin reactions of Grade 3 or above were reported in 5% of patients2

Although often mild-to-moderate in severity, they can be uncomfortable and may impair daily activities15

Hand-foot skin reactions associated with INLYTA® may be reduced if patients are adequately educated and follow preventative advice and easily treated if reported early.

Prevention 
Before starting INLYTA® therapy, help patients to minimise the risk and severity of hand-foot skin reactions by encouraging them to:

• Visit a podiatrist to remove existing hyperkeratotic areas and calluses6,11
• Reduce exposure of hands and feet to hot water11
• Avoid constrictive clothing and footwear11
• Avoid vigorous exercise that may result in excessive rubbing and friction on the skin11
• Wear open shoes with padded soles and gloves6,11
• Apply alcohol-free moisturising creams after bathing and regularly use moisturising creams (e.g. urea- containing creams)10,11

Educate patients to look for the visible signs of hand-foot skin reactions and the 3C approach for managing the condition:11,15

• Control calluses
• Comfort with cushions
• Cover with creams

Signs and Symptoms 

• Hand-foot skin reactions usually occur on the palms of the hands or soles of the feet but may affect other areas15
• Skin can become red, swollen and painful – sometimes with blisters, cracks and/or peeling15
• Hand-foot skin reactions are often preceded or accompanied by tingling or numbness15

Assessment  

• Confirm the presence of hand-foot skin reactions
• Assess severity of hand-foot skin reactions as their impact may differ from patient to patient (see Table 8 for grading)12

Questions for your Patients 

• Have you felt any tingling sensations?
Skin changes are often preceded by a tingling sensation in the hands and feet


• Can you hold a cup of tea? Is wearing shoes unbearable? What is your hand-foot skin reaction preventing you from doing?
It is vital to assess the severity of hand-foot skin reactions for everyone.


• Are you noticing any skin changes, such as a change in colour, feel or sensation?
Encourage your patients to regularly examine their skin and discuss any changes or concerns they have with you at the clinic and by phone in-between visits.


• Do you have any skin changes in other areas?
Remember that hand-foot skin reaction can occur in areas of the body beyond the hands and feet, which patients may not want to disclose immediately

Management
Provide supporting advice to patients if they suffer hand-foot skin reactions, and further encourage patients to:


• Avoid/reduce activities that put a lot of pressure on the affected areas11
• Wear loose, comfortable clothes and shoes, and use cushioned insoles6,11 - Avoid exposure to hot water11
• Protect tender areas, pressure points with padding, foam absorbents and shock absorbers11,15

Symptoms can be alleviated using:

• Moisturising emollient creams and urea-based creams, especially for the feet11
• Daily foot soaks in lukewarm water with Epsom salts for 20–30 minutes15
Grade 3 hand-foot skin reactions may require treatment interruption or dose adjustment
10.
 
Grading Hand–Foot Skin Reactions12​​​​

Grade

Characteristics

1

Minimal skin changes or dermatitis (e.g. erythema) without pain

2

Skin changes (e.g. peeling, blisters, bleeding, oedema) or pain, not interfering with function

3

Ulcerative dermatitis or skin changes with pain interfering with the function

Grade

Characteristics

1

Minimal skin changes or dermatitis (e.g. erythema) without pain

2

Skin changes (e.g. peeling, blisters, bleeding, oedema) or pain, not interfering with function

3

Ulcerative dermatitis or skin changes with pain interfering with the function

Management Strategies for Hand-Foot Skin Reactions11

Grade

Strategy

1

Continue at same dose
Treat with moisturising creams and topical ointments, and encourage measures to avoid skin irritation10

2

Continue at the same dose
Treat with moisturising creams and topical ointments, and encourage measures to avoid skin irritation10

3

Interrupt INLYTA® therapy until Grade 1 or baseline levels10
Resume INLYTA® at reduced dose levels

Grade

Strategy

1

Continue at same dose
Treat with moisturising creams and topical ointments, and encourage measures to avoid skin irritation11

2

Continue at the same dose
Treat with moisturising creams and topical ointments, and encourage measures to avoid skin irritation11

3

Interrupt INLYTA® therapy until Grade 1 or baseline levels11
Resume INLYTA® at reduced dose levels

Fatigue / asthaenia

What to look for  
Fatigue of all grades was reported in 39% of patients on INLYTA® in the Phase III AXIS study2

•​​​​​​​ Fatigue of Grade 3 or above was reported in 11% of patients2

Several factors may contribute to fatigue in patients with RCC, including anaemia, hypothyroidism, depression and other co-morbidities6,10,11,16

Fatigue may be related to both the disease and psychosomatic factors related to the disease11,16

Prevention
Identify and resolve underlying factors that may affect the level of fatigue:11

• Anaemia
• Thyroid function
• Pain control

Review concomitant medications and comorbidities that may cause fatigue10,11

Advise patients that they may feel tired once INLYTA® therapy begins.
Advise patients of lifestyle modifications to minimise the impact of fatigue, including:

• Conserve energy6,11
• Accept help from others6
• Reschedule activities to periods of peak energy11
• Stay active11,16
• Try to maintain a normal sleep pattern18
• Use relaxation techniques to alleviate stress11,16
• Modify diet6,11

Signs and symptoms 
Look out for changes in patient activities and attention on the telephone or in the clinic.

Check for underlying factors that may affect the level of fatigue; for example, hypothyroidism, anaemia and dehydration6,10,11

Assessment  

• Confirm the presence of fatigue
• Take a full history to check concomitant medicines and comorbidities before initiating treatment6,10
• Encourage patients to rate their fatigue on a numeric scale, where 0= 'no fatigue' and 10=' worst fatigue imaginable.'
• Assess severity of fatigue as its impact may differ from patient to patient12

Questions for your Patients 

• Have you been feeling more tired than usual since you started taking INLYTA®?
It is important to have educated your patient to tell you that as soon as a side effect, like fatigue, becomes troublesome, the most appropriate supportive care can be promptly provided.


• Do you do any exercise?
Light physical exercise may reduce fatigue levels and help your patient get a better night's sleep.


• How does your fatigue affect your everyday life?
The severity and impact of fatigue may differ from patient to patient

Management 

• Treatment of fatigue is supportive in nature – reinforce preventative advice (see Prevention for more details)
• Encourage patient to pace themselves and schedule activities to times of peak energy6,11
• Baseline and ongoing monitoring of thyroid function6
• Identify and treat all fatigue-inducible factors to optimise quality of life (daily activities, comfort, associated pain, emotional distress, depression and nutrition disorders)6, 10,11
• Grade 3 or 4 fatigue may require treatment interruption or dose adjustment (see Table 7 for management recommendation)10,11

Grading Fatigue12
​​​​​

Grade

Characteristics

1

Mild fatigue over baseline

2

Moderate fatigue causing difficulty performing some activities of daily life

3

Severe fatigue interfering with activities of daily life

4

Disabling

Grade

Characteristics

1

Mild fatigue over baseline

2

Moderate fatigue causing difficulty performing some activities of daily life

3

Severe fatigue interfering with activities of daily life

4

Disabling

Grading Management Strategies for Fatigue10

Grade

Strategy

1

Continue at same dose
Lifestyle modifications and provide supportively care

2

Continue at the same dose
Lifestyle modifications and provide supportive care

3

Decrease INLYTA® dose to one lower level

4

Interrupt INLYTA® therapy
Resume INLYTA® at one lower dose level once fatigue is Grade 2 or lower

Grade

Strategy

1

Continue at same dose
Lifestyle modifications and provide supportively care9

2

Continue at the same dose
Lifestyle modifications and provide supportive care

3

Decrease INLYTA® dose to one lower level

4

Interrupt INLYTA® therapy
Resume INLYTA® at one lower dose level once fatigue is Grade 2 or lower

Diarrhoea

What to look for
Diarrhoea of all grades was reported in 55% of patients on INLYTA® in the Phase III AXIS study2

•​​​​​​​ Diarrhoea of Grade 3 or above was reported in 11% of patients2

Diarrhoea can lead to dose interruption or reduction of INLYTA®10 and requires early and ongoing evaluation and intervention.
6

Diarrhoea associated with anti-cancer therapy can lead to aversions to some foods, with subsequent weight loss and reduced quality of life, and be potentially life-threatening if not managed appropriately11
• Weight loss of all grades was reported in 25% of patients on INLYTA® in the Phase III AXIS study2
• Decreased appetite of all grades was reported in 34% of patients on INLYTA® in the Phase III AXIS study2

Prevention 
Before starting INLYTA® therapy, help minimise the risk and severity of diarrhoea in patients by:

• Assessing baseline bowel habits, including frequency and consistency of stools and the use of laxative or stool softener6
• Reviewing concomitant medicines, such as opioids6
• Consulting with a dietician, if necessary or appropriate11

Encourage patients to modify their diet:

• Bananas, rice, apple and toast can slow gastrointestinal motility and increase stool consistency11,16
• Reduce intake or try to avoid diarrhoea-enhancing foods and drink, for example, high-fibre foods, caffeine, alcohol and dairy products6,10,11,16

Patients should avoid grapefruit or juice throughout their treatment with INLYTA® since these may increase plasma concentrations of INLYTA® and the risk of side effects.1

Advise patients that diarrhoea is associated with INLYTA® therapy and the importance of reporting diarrhoea to the healthcare team early as it can be life-threatening if not managed before.

Signs and symptoms17
Common signs of diarrhoea include:
• Increased frequency of stools
• Loose, watery stools
• Incontinence
• Abdominal pain

Assessment  

• Confirm the presence of diarrhoea
• Take a full history to check concomitant medications and co-morbidities6,10
• Evaluate the severity of diarrhoea as its impact may differ from patient to patient (see Table 3 and 4 for grading and management recommendations)12

Questions for your Patients 

• Have you experienced an increase in diarrhoea, indigestion or flatulence since starting INLYTA®?
Changes in bowel movements are widespread with INLYTA®, but symptoms are usually mild to moderate


• How does your diarrhoea affect your everyday life?
The severity and impact of diarrhoea may differ from patient to patient


• What is your diet like?
Eating foods that slow gastrointestinal motility and increase stool consistency, and reducing intake or trying to avoid diarrhoea-enhancing foods and drink can help reduce the frequency and severity of diarrhoea

Management
Patient education regarding diet and hydration is recommended
10
• Consultation with a dietician should be considered11

Encourage patients to:

• Avoid the use of stool softeners or fibre supplements11
• Avoid spicy, high-fibre and fatty foods and caffeine6,10,11,16
• Eat and drink often in small amounts16
• Use anti-diarrhoeal treatments (e.g. loperamide), and dehydration management6,10,11,16
• Keep a diary to help monitor their bowel movements and highlight any factors that may make symptoms worse11
• Consider dose reduction or interruption as necessary and then re-escalate1

Grading Diarrhoea12
​​​​​

Grade

Characteristics

1

Increase of <4 stools per day over baseline
Mild increase in ostomy output compared with baseline

2

Increase of 4–6 stools per day over baseline
Moderate increase in ostomy output compared with baseline
Intravenous fluids indicated <24 hours
Not interfering with activities of daily life

3

Increase of ≥7 stools per day over baseline
Severe increase in ostomy output compared with baseline
Intravenous fluids indicated ≥24 hours
Interfering with activities of daily life
Incontinence
Hospitalisation

4

Life-threatening consequences (e.g. haemodynamic collapse)

Grade

Characteristics

1

Increase of <4 stools per day over baseline
Mild increase in ostomy output compared with baseline

2

Increase of 4–6 stools per day over baseline
Moderate increase in ostomy output compared with baseline
Intravenous fluids indicated <24 hours
Not interfering with activities of daily life

3

Increase of ≥7 stools per day over baseline
Severe increase in ostomy output compared with baseline
Intravenous fluids indicated ≥24 hours
Interfering with activities of daily life
Incontinence
Hospitalisation

4

Life-threatening consequences (e.g. haemodynamic collapse)

Management Strategies for Diarrhoea10

Grade

Strategy

1

Continue at the same dose
Dietary and dehydration management
Anti-diarrhoeal treatments, as required

2

Continue at the same dose
Dietary and dehydration management
Anti-diarrhoeal treatments, as required

3

Hospital admission required to manage diarrhoea
Decrease INLYTA® dose to one lower level to continue INLYTA®, where appropriate

4

Hospital admission required to manage diarrhoea
Interrupt INLYTA® therapy
Resume INLYTA® at one lower dose level once diarrhoea is Grade 2 or lower, if appropriate

Grade

Strategy

1

Continue at the same dose
• Dietary and dehydration management
• Anti-diarrhoeal treatments, as required

2

Continue at the same dose
Dietary and dehydration management
Anti-diarrhoeal treatments, as required

3

Hospital admission required to manage diarrhoea
Decrease INLYTA® dose to one lower level to continue INLYTA®, where appropriate

4

Hospital admission required to manage diarrhoea
Interrupt INLYTA® therapy
Resume INLYTA® at one lower dose level once diarrhoea is Grade 2 or lower, if appropriate

Hypothyroidism

What to look for  
Hypothyroidism of all grades was reported in 19% of patients on INLYTA® in the Phase III AXIS study2

•​​​​​​​ Hypothyroidism of Grade 3 or above was reported in <1% of patients2

Prevention 

• Monitor thyroid function before initiation of INLYTA® treatment1,6
• Treat any existing hypothyroidism before starting INLYTA® therapy using standard medical practice to achieve and maintain a euthyroid state1
• Advise patients that hypothyroidism may develop with INLYTA®

Signs and symptoms 
Symptoms of hypothyroidism include:18

• Fatigue
• Swelling around the eyes
• Dry skin
• Shortness of breath
• Feeling cold
• Anorexia19
• Fluid retention19
• Skin and hair alterations19

Several of these symptoms can also be independent side effects of INLYTA® therapy1

Typical symptoms are consistent with declining metabolic functions, including:19

• Fatigue
• Changes in mental function and memory
• Lethargy
• Weight gain
• Cold intolerance 

Assessment  

• Confirm the presence of hypothyroidism
• Take a patients full medical history to check concomitant medications and comorbidities before initiating treatment6,10
•​​​​​​​ Thyroid function should be monitored before initiation of INLYTA® and periodically after that during treatment1,6,19
• Consider assessing levels of thyroid-stimulating hormone, triiodothyronine and thyroxine/free thyroxine index at baseline and every 10–12 weeks.6 Assess severity of hypothyroidism as its impact may differ from patient to patient12

Questions for your Patients 
• Have you been feeling more tired than usual since you started taking INLYTA®?
It is important to have educated your patient about potential side effects and to tell you as soon as any become troublesome so that the most appropriate supportive care can be promptly provided


• Have you experienced fatigue, swelling around the eyes or feeling cold since you started taking INLYTA®?
These symptoms may be indicative of hypothyroidism and will require assessment and possible treatment


• How do the symptoms of hypothyroidism affect your everyday life?
The severity and impact of hypothyroidism may differ from patient to patient

Management  
Monitor patient for signs and symptoms of hypothyroidism. Hypothyroidism can be managed with thyroid hormone replacement therapy6,19

• Initiate levothyroxine treatment if required, based on laboratory results to maintain euthyroid state6,19

Grading Hypothyroidism12​​​​​​​

Grade

Characteristics

1

Asymptomatic, intervention not indicated

2

•​​​​​​​ Symptomatic, not interfering with activities of daily life
• Thyroid replacement

3

Symptoms interfering with activities of daily life
•​​​​​​​ Hospitalisation indicated

4

Life-threatening myxoedema coma

Grade

Characteristics

1

Asymptomatic, intervention not indicated

2

•​​​​​​​ Symptomatic, not interfering with activities of daily life
• Thyroid replacement

3

Symptoms interfering with activities of daily life
•​​​​​​​ Hospitalisation indicated

4

Life-threatening myxoedema coma

Management strategies for Hypothyroidism10

Grade

Strategy

1

Continue at same dose

2

Continue at the same dose

3

Decrease INLYTA® dose to one lower dose level

4

Interrupt INLYTA® therapy
•​​​​​​​ Resume INLYTA® at one lower dose level once the hypothyroidism is Grade 2 or lower

Grade

Strategy

1

Continue at same dose

2

Continue at same dose

3

Decrease INLYTA® dose to one lower dose level

4

Interrupt INLYTA® therapy
•​​​​​​​ Resume INLYTA® at one lower dose level once the hypothyroidism is Grade 2 or lower


AE : Adverse Event

References
  1. INLYTA® Summary of Product Characteristics for Great Britain click here. INLYTA® Summary of Product Characteristics for Northern Ireland click here.
  2. Rini BI, et al. Lancet 2011;378:1931-1939.
  3. Melichar B, et al. Efficacy and tolerability of axitinib in metastatic renal cell carcinoma (mRCC): comparison of Czech clinical registry and AXIS trial data. ECC. 25–29 September 2015. Vienna, Austria. Poster: 2615.
  4. Matias M, et al. Eur J Cancer 2017;79:185–192.
  5. Rossetti S, et al. Activity of second line axitinib in metastatic renal cell carcinoma (mRCC) patients treated with sunitinib: results from SAX Italian real world trial. ASCO. 2–6 June 2017. Chicago, USA. Abstract: e16054.
  6. Wood LS, et al. Commun Oncol 2012;9:46–55.
  7. National Institute for Health and Clinical Excellence. NICE clinical guideline 136. Hypertension – Clinical management of primary hypertension in adults, 2019. Available at: https://www.nice.org.uk/guidance/ng136. Accessed: March 2022.
  8. Williams B, et al. BMJ 2004;328:634–40.
  9.  INLYTA® Patient Information Leaflet. Available at: https://www.medicines.org.uk/emc/product/7948/pil. Accessed: March 2022.
  10. Cohen RB, Oudard S. Invest New Drugs 2012;30:2066–79.
  11. Eisen T, et al. J Natl Cancer Inst 2012;104:93–113.
  12. National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Publish Date: August 9, 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed: March 2022.
  13. Schwartz SR, et al. Otolaryngol Head Neck Surg 2009;141: S1–S31.
  14. Wood JM et al. BMJ 2014;349:g5827.
  15. Wood LS, et al. Commun Oncol 2010;7:23–9.
  16. Appleby L, et al. Hematol Oncol Clin North Am 2011;25: 893–915.
  17. Cancer Research UK. Symptoms of diarrhoea, 2019. Available at: https://www.cancerresearchuk.org/about-cancer/coping/physically/bowel-problems/types/diarrhoea/symptoms. Accessed: March 2022.
  18. Pyle L, et al. Commun Oncol 2008;7:42–6.
  19. Torino F, et al. Nat Rev Clin Oncol 2009;6:219–28.
PP-INL-GBR-0815. April 2022

Indication

  • INLYTA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (aRCC) after failure of prior treatment with sunitinib or a cytokine1

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