Make room for new IVIG--this one from a foreign firm
Make room for new IVIGthis one from a foreign firm
Those familiar with intravenous immune globulins (IVIG or IGIV) will recall that increased demand, tampering problems, and manufacturing deficiencies have led to shortages of the drug. Because of these supply problems, the Food & Drug Administration has encouraged foreign manufacturers of IVIG to seek U.S. approval. Octapharma AG was the first company to respond.
"The first time Octapharma was approached, there was a shortage of IGIV in the United States," said Wolfgang Frenzel, M.D., medical director for Octapharma AG. Although that shortage has been resolved, there is still potential for another one. Primary immune deficiencies are severely underdiagnosedthe estimated average time to diagnosis for these patients is about eight years, according to the Immune Deficiency Foundation (IDF). The foundation has begun an educational campaign to alert doctors to the problem.
While this is good news for patients, IDF predicted that earlier diagnosis could result in increased demand for IVIGas much as double, in fact. Jonathan Goldsmith, M.D., interim president and VP, medical affairs, for IDF, added, "IDF continues to be concerned about an adequate supply of IGIV products due to recent mergers and acquisitions in the plasma protein industry." Apparently, adequate supply of IVIG is also a major concern for patients. In a survey conducted by IDF in 2002, 64% of patients who use IVIG reported reliability of supply was a major concern.
Adverse reactions to IVIG have been a concern as well. Some patients have developed serious renal complications after receiving IVIG, and others have suffered from thrombosis. The renal complications have been attributed to sucrose added to certain IVIG products, and the thrombosis occurrences may be due to administering the IVIG too quickly. However, as no one knows for sure, all IVIG products carry warnings about potential renal and thrombosis problems.
Just approved by the FDA in May, Octapharma's IVIG product will soon be added to the mix. The firm has been marketing Octagam in Europe for 10 years. To remain on the safe side, Octapharma chose not to add sucrose to Octagam. Goldsmith said, "This may make it safer from a renal perspective." Maltose is added to Octagam to help regulate osmolarity.
Octapharma has also kept sodium content to a minimum. "Products with high levels of sodium may cause renal dysfunction, cardiac impairment, and hyperviscosity, leading to thromboembolic episodes," said Frenzel.
IVIG is obtained from donated human plasma, so purity is naturally a big issue. No one wants to see a single case of viral transmission due to contaminated IVIG. Some of the IVIG products approved in recent years have incorporated new research and technology to improve purification methods. Makers of these IVIGs claim the newer methods increase purity and result in better quality IVIG.
Octagam is purified in conventional but tried-and-true methods. Octapharma uses solvent/detergent treatment and mild acidification to purify the immune globulins. These methods have become the standard in IVIG production. Octapharma said that while Octagam may not have innovative production methods, it has a proven reliability and safety record in Europe. There have been no reports of virus transmission since the product was first marketed overseas.
Adverse events have also been minimal, according to the firm. "In Germany, a postmarketing surveillance study has been conducted since 1995, investigating the safety [and efficacy] of Octagam 5%," said Frenzel. In documenting about 81,000 infusions in 5,600 patients, "the incidence of reported side effects is very lowless than one-half percent," he said.
In IDF's 2002 survey, patients listed efficacy, safety, and tolerability, in that order, as the most important factors in deciding to switch to another product. Most patients also expected newer products would be better, although they preferred established manufacturing plants to new ones. While Octagam may not be a flashy new addition to the market, it does have a solid track record, a quality some patients may prefer to fancy new production techniques.
Jillene Magill-Lewis, R.Ph.
The author is a medical writer based in the Seattle area.
TIPS TO REMEMBER: Octagam
- Octagam may be stored at room temperature for up to 18 months or refrigerated for up to 24 months.
- Vials of Octagam are for single use only.
- As with all IVIG products, Octagam should be used with caution in patients with renal failure or at risk for renal failure. Renal dysfunction and failure, sometimes fatal, have been associated with IVIG use.
- Some cases of aseptic meningitis and migraine, hemolytic anemia, and increases in liver function tests have occurred with Octagam use. These reactions were reversible with discontinuation of the drug.
Jillene Lewis. Make room for new IVIG--this one from a foreign firm. Drug Topics Jul. 12, 2004;148:36.