Important FDA Update Regarding Iron Infusions 

There’s been a change to the safety label for Injectafer®, an iron infusion often used to treat iron deficiency. The FDA now includes HHT as a risk factor for developing symptomatic hypophosphatemia (low phosphate levels), a condition that can affect up to 70% of patients who receive Injectafer. 

This important update comes from Cure HHT’s Scott Olitsky, MD, our Global Center of Excellence and Outreach Director, in collaboration with leading HHT hematologists. Want to learn more? Check out the FAQ below for more information. 

What does this mean? 

HHT patients who use Injectafer to treat iron deficiency are at a greater risk of developing symptomatic hypophosphatemia. This condition is characterized by low levels of phosphate in the blood, which can cause muscle and bone pain, bone demineralization and fractures. Severe cases may be life threatening. It should be noted that HHT by itself is not the risk factor for this complication. Because many patients with HHT get repeated infusions, this is what places them at risk. However, it should be emphasized that this complication can occur with a single infusion. 

Why is this important? 

Iron deficiency is a common side effect of HHT and some patients require routine iron infusions as part of their care management. Injectafer is often the primary choice of iron replacement used by infusion centers. People with HHT who are receiving iron infusions, particularly if they are receiving them outside an HHT Center of Excellence, should understand what other iron replacement options are available to them.  

How do I know if I have symptomatic hypophosphatemia? 

Early stage symptomatic hypophosphatemia can often appear similar to anemia and it may be hard to distinguish between the two. A doctor will be able to determine through blood testing if you have this condition. 

I’ve received Injectafer infusions within the past six months — what should I do? 

Speak to your primary HHT care provider to ensure they are aware of your situation and can agree on an alternate care plan. If you are experiencing any of the symptoms listed above, or any other symptoms of symptomatic hypophosphatemia, visit an HHT Center of Excellence to determine the best care. It is recommended not to receive any more Injectafer infusions. 

How can I safely get iron supplementation if I need it? 

If you have already been receiving iron infusions as part of treatment for HHT, then you will most likely need to continue infusions. Oral supplements are typically not successful in treating active bleeding or significant anemia, though they may be helpful in milder cases of iron deficiency. There are several other iron infusion treatments available.  

What should I tell my doctor about these updates? 

If you regularly see a physician at an HHT Center of Excellence then it’s likely they are already aware of this update. Physicians working in general care clinics and even some hematologists may need to be informed of the new safety label information. Provide them with the information above, as well as the below list of commonly available iron products that have significantly less risk of producing hypophosphatemia. 

Venofer 

Venofer is generally given in relatively small doses — 200mg. Most HHT patients should receive 1000mg of iron. Therefore it will require five infusions to receive the full dose. Venofer is well tolerated and can be infused fairly quickly, but the need for 5 infusions may be problematic for many patients.  

Iron Dextran 

Iron dextran is an older iron preparation. It is well tolerated by most people and can be given as a 1000mg infusion in a single sitting. The first infusion usually requires a test dose and subsequent infusions take a few hours. Iron dextran is less costly and covered by many insurance companies. Some patients may opt for the longer fusion time to avoid having to make multiple trips to receive a full dose of iron replacement.   

Ferumoxytol  

Ferumoxytol (Feraheme) is generally given as two separate 520mg infusions, about three to eight days apart. Feraheme can be given as a fairly rapid infusion. Though studies have shown that it’s safe to give both doses at once, it was not initially approved to be given this way and most infusion centers have to administer the doses separately.  

Ferric Derisomaltose 

Ferric Derisomaltose (Monofer) is a newer iron preparation. A full dose of iron can be given fairly rapidly in one sitting. This option is a convenient way for patients to receive a full dose of iron in one visit in less time than it would take to give iron dextran.