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Asunra treats iron overload due to blood transfusions with just one oral dose a day and has bee proven to reduce iron burden in patients.

“All About Treatment With Asunra ” was written especially for healthcare professionals to use as a reference tool. It contains information on Asunra dosing, monitoring, and side effects, and will better enable you to answer patient's questions about Asunra , allay their concerns, and help them feel positive about their therapy.

By knowing what to expect, patients maybe more likely to comply with and stay on their treatment. And that is key to achieving the goals of therapy: reducing iron burden or maintaining iron balance to avoid the dangerous consequences of transfusional iron overload.

Why chelation is necessary for your patients

Blood transfusions can be life-saving and are essential therapy for many patients with chronic anemias. But transfused blood introduces extra iron into the body. Iron, a component of red blood cells, plays an important role in key body functions but can be toxic at elevated levels. The body cannot eliminate excess iron on its own, so iron builds up with each transfusion. This can cause a condition called iron overload. Iron overload can occur in vital organs such as heart, liver and endocrine system, leading to severe organ damage. Left untreated, iron overload can significantly reduce life span.

Iron chelators remove excess iron from the body and reduce the risk of it causing organ damage. Therefore, when a patient passes the 20-unit threshold, physicians should consider wether to administer chelaton therapy.

Asunra is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients ( aged 2 years and over). Asunra has been proven to deliver, in a once-daily oral formulation, safe and effective, continuous 24- hour iron chelation for patients with transfusional iron overload. A prescription for Asunra means your patient has started a convenient-to-follow, effective plan for treating their transfusional iron overload.

How to take Asunra
Why take Asunra ?

Asunra is the only iron chelator to provide 24- hour coverage with a convenient, once-daily oral dose¹º

When to take Asunra ¹

Take Asunra once a day, at the same time every day, to maintain continuous 24-hour benefit.

• Take Asunra on an empty stomach. Wait at least 30 minutes before eating any food.

• Taking Asunra at the same time every day will help patients remember when to take their tablets and ensure that they maintain continuous chelaton coverage. Taking Asunra in the evening rather than the morning may help relieve some GI effects.

How to take Asunra ¹

	DROP the tablet(s) into a glass of orange juice, apple juice or water (100 mL or 200 mL).
	STIR until the tablet(s) are completely dissolved. The liquid in the glass will look cloudy. The cloudy liquid means the medicine is mixed in.
	DRINK everything in the glass. Then, add a little juice or water to what's left in the glass and drink that too. It's important that you drink it all, because this is how you get the right amount of medication.

Managing some common side effects seen with Asunra
Asunra has a demonstrated safety profile

Asunra has a manageable side-effect profile and when patients do experience side effects, they are generally mid to moderate and transient. Most side effects go away within a few days to a few weeks of therapy.

Asunra works over time to reduce iron, so it may take several months before results are evident. During this time, it is very impotant for patients to continue taking Asunra as directed and find ways to, when possible, manage transient side effects in order to achieve the benefits of Asunra therapy.

The following is the breakdown of commonly reported side effects and helpful tips on how to manage them. You can use this information as a reference if your patients come to you with questions about side effects and what to expect.

Gastrointestinal disturbances

Gastrointestinal disturbances (mainly nausea, vomiting, diarrhea, or abdominal pain) occurred in approximately 26% of patients in clinical trails.¹ They were usually of short duration and only 4 patients (less than 1%) discontinued therapy due to Gastrointestinal disturbances.¹º

Diarrhea was reported more often in pediatric patients aged 2 to 5 years than in older children and adults.¹¹ For patients in whom diarrhea or vomiting develops, care should be taken to maintain adequate hydration, especially in older patients and in those who have experienced an increase in serum creatinine.¹,¹² Incresed serum creatinine levels can be associated with renal dysfunction.¹³ Poor hydration can further impact renal health.¹² If gastrointestinal symptoms persist, advise patients that taking their Asunra dose in the evening rather than morning may help to alleviate them.

Hypersensitive reactions

Rare cases of anaphylaxis and angiodema have been reported.¹ If reactions are severe, Asunra should be discontinued and appropriate medical intervention instituted.

Skin rash

Skin rash was seen in about 7% of patients and was mostly mild to moderate, and generally transient.¹ For mild to moderate rashes, Asunra maybe continued without dose adjustment, since the rash often resolves spontaneously. More severe rashes may require interruption of treatment.

After resolution of the rash, Asunra may be reintroduced at a lower dose, followed by gradual dose escalation. For patients with severe rash, this reintroduction may be conducted in combination with a short period of oral steroid administration. Rare cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving Asunra, with the onset of the reaction occurring in the majority of cases within the first month of treatment. If reactions are severe, Asunra should be discontinued and appropriate medical intervention instituted.

Monitoring during treatment with Asunra

Patients should be tested prior to starting Asunra and during treatment to monitor efficacy and safety. This monitoring will help ensure that your patient is having an optimal response to therapy and will provide an opportunity for early intervention if necessary.

Serum ferritin

Serum ferritin trends have been shown to parallel the changes in liver iron concentration and therefore can be used as a marker of iron levels. ¹ This simple blood test is an effective way to monitor iron levels without an invasive procedure such as biopsy. Patients with a history of increased serum ferritin and multiple transfusions are at greatest risk of iron overload.

Monthly measurement of serum ferretin is recommended to assess the patient's response to Asunra. This test helps to determine wether a patient needs an adjusted dose of Asunra or should continue on the current dose. Dose adjustments of 5 mg/kg to 10 mg/kg can be made every 3 to 6 months based on serum ferritin trends. If serum ferritin consistently falls below 500 µ/L, it means that Asunra has brought iron levels down far enough that reductions are no longer needed. Therefore, Asunra therapy can be interrupted or the dose adjusted to maintain iron levels.

Serum creatinine

In clinical trials, about 36% of patients experienced nonprogressive increases in serum creatinine, mostly within the normal range. ¹ These increases were dose dependent and often resolved spontaneously. If they did not resolve spontaneously, these increases were generally occurred within the first few weeks of treatment. ¹¹

Serum creatinine should be monitored twice before initiating therapy and at least monthly thereafter. ¹Obtaining a baseline assessment on 2 consecutive occasions is recommended because variation in measurements is common.

Spontaneously reported adverse reactions, including cases of acute renal failure, have been reported following the postmarketing use of Asunra. ¹ These adverse reactions were reported voluntarily and it is not always possible to reliably establish frequency or a casual relationship to drug exposure.

Proteinuria

In addition to serum creatinine, urine protein tests are another way to assess renal function. Therefore, tests for proteinuria should be performed monthly as a precaution.

Liver function

Patients with transfusional iron overload may have compromised liver function. As a result, liver function should be monitored monthly. When liver iron burden was reduced in patients taking Asunra, transaminase levels also tended to decrease. ¹º In clinical trials of Asunra, elevations of liver transaminases were reported as an adverse reaction in approximately 2% of patients. ¹ These increases were not dose dependent, and most patients presented with elevated levels prior to starting Asunra. Elevations of transaminases greater than 10 times the upper limit of the normal range, which is suggestive of hepatitis, were uncommon (0.3%). ¹ if there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, Asunra should be interrupted.

Auditory and ophthalmic

In clinical trials, less than 1% of patients reported auditory changes (hearing loss) or ocular side effects (early cataracts, maculopathy). ¹ Despite thae fact that auditory or ocular effects are very rare, patients should have their ear and eye function tested before initiating therapy, and then once every year while they remain on Asunra. If auditory or ocular function disturbances are noted, the dose of Asunra can be reduced or possibly interrupted.

Growth and development

Asunra has not been associated with growth retardation in children. However, as a precautionary measure, it is recommended that pediatric height and weight be monitored annually.